Oncology clinical trials are at the forefront of progress in the fight against cancer, offering patients access to promising new treatments while advancing medical knowledge. These carefully designed studies test innovative therapies—from cutting-edge immunotherapies to targeted treatments—with the goal of improving survival rates, reducing side effects, and enhancing quality of life. By participating in an oncology clinical trial, patients become partners in discovery, helping to shape the future of cancer care. Our expert team is dedicated to providing compassionate support and expert guidance throughout every step of the clinical trial journey.
Oncology: Clinical Studies Open For Enrollment
We have clinical trials available in these subspecialties of oncology:
- Solid Tumors (19)
- Brain Tumors (9)
- Sarcoma (1)
- Mesothelioma (1)
- Non-Small-Cell Lung (2)
Solid Tumors
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Eligibility
- Subject is between 1 year and 30 years of age
- Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04308330
Principal Investigator
Jeremy Rosenblum, MD
Contact for Study Screening
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Eligibility
- There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT)
- Standard risk 1: Patient must be less than 11 years of age at enrollment
- Standard risk 2: Patients must be at least 11 and less than 25 years of age at enrollment
- Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher)
- Low risk stage I immature teratoma (IT); site: ovarian; stage: Children’s Oncology Group (COG) stage I; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma; tumor markers: alpha-FP less than or equal to 1,000 ng/mL, beta-HCG institutional normal; all ages
- Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
- Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
- Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age less than 11 years
- Standard risk 2 (SR2)
- Site: ovarian; stage: COG stage II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
- Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP less than 1,000 ng/mL, beta-HCG less than 5,000 IU/mL and lactate dehydrogenase (LDH) less than 3.0 x normal; age at least 11 and less than 25 years
- Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03067181
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between 1 year and 30 years of age
- Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
- The following disease groups are eligible:
- Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
- MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; or
- Age greater than 547 days regardless of biologic features
- Patients with INRG stage MS disease with MYCN amplification
- Patients with INRG stage L2 disease with MYCN amplification
- Patients greater than 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within four weeks of progression to stage M
- Patients at least 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within four weeks of progression to stage M
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03126916
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between 11 – 45 years of age
- Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma), or
- Exceptionally raised tumor markers (AFP at least 1000ng/mL and/or HCG at least 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
- Primary arising in testis, ovary, retro-peritoneum, or mediastinum
- Metastatic disease or non-testicular primary
- Intermediate or poor prognosis
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT02582697
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between 1 month and 17 years of age
- Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
- Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04570423
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Subject is no older than 30 years of age
- Newly diagnosed stages 2 – 4 diffuse anaplastic Wilms tumor
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04322318
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is no older than 30 years of age
- Newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03533582
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between 12 – 39 years of age
- Osteosarcom having received at least standard initial therapy
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04616560
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
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Eligibility
- Subject is no older than 50 years of age
- Osteosarcoma
- Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of first recurrence following completion of therapy for initially localized disease
- Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05235165
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Subject is between 3 years and 22 years of age
- Must be newly diagnosed medulloblastoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05382338
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors
- Renal medullary carcinoma
- Malignant rhabdoid tumor (extra-CNS)
- Atypical teratoid rhabdoid tumor (CNS)
- Poorly differentiated chordoma
- Epithelioid sarcoma
- Other SMARCB1 or SMARCA4 deficient tumors
- Subject must be at least 12 months of age
- Part A, patients must be less than 18 years old
- Part B, patients must be 18 years or older
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05286801
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
- Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors
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Eligibility
- Patients must be less than 40 years of age at time of enrollment.
- Patients must have a body surface area of greater than or equal to 0.8m2 at the time of enrollment.
- Patients must have a histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05691478
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male or female ≤ 30 years at the time of initial diagnosis with high-risk disease
- Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
- Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
- Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
- Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
- Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
- Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
- Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
- Exclusion Criteria
- Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
- Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
- Patients with known bone marrow failure syndromes
- Patients on chronic immunosuppressive medications (eg, tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
- Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
- All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06172296
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male or female < 18 years of age
- For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues
- For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma
- Exclusion Criteria
- History of solid organ transplant
- Clinically significant (ie, active) cardiovascular disease
- Known history of liver cirrhosis
- Ongoing Grade >1 peripheral neuropathy
- Demyelinating form of Charcot-Marie-Tooth disease
- Diagnosed with Down syndrome
- Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis
- History of human immunodeficiency virus (HIV) infection
- Contraindication or hypersensitivity to any of the study intervention components
- Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities
- Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1)
- Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06395103
Principal Investigator
Andrew Bellantoni, MD
Contact for Study Screening
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Eligibility
- Male or female ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Must have a locally advanced or metastatic inoperable tumor as follows:
- For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.
- For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion/exclusion criteria will be updated.
- Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the Investigator’s assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.
- In the Investigator’s opinion, the subject may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the subject failed or did not tolerate one or more of other anticancer therapies:
- For the dose escalation phase:
- Refractory, intolerant, or refused available standard-of-care therapies.
- Up to three previous lines of systemic anticancer therapies for metastatic disease are allowed (adjuvant or neoadjuvant setting do not count as lines of systemic therapy).
- Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA) approved treatments prior to enrolling in this study (e.g., iPARP).
- Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.
- Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
- Subjects with HCC must have confirmed diagnosis of inoperable hepatocellular carcinoma by histology or clinical/radiological criteria. No more than two prior lines of
systemic therapy only and Child Pugh Score A or B7.
- For the expansion phase:
- For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.
- Cohort 1 ST316 monotherapy: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of four prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-vascular-endothelial growth factor (VEGF), anti-epidermal growth factor receptor (EGFR) targeted agents (as indicated).
- Cohort 2: Combination with standard of care (SOC) FOLFIRI +bevacizumab: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of one prior line of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
- Cohort 3: Combination with fruquintinib: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
- Cohort 4: Combination with Lonsurf + beva: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
- Evaluable disease per RECIST 1.1 with at least one target lesion.
- All previous anticancer therapy-related AEs should have resolved to Grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune CPIs.
- For the dose escalation phase:
- Exclusion Criteria
- Known hypersensitivity to ST316 or any of its excipients.
- Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion.
- Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) > 480 msec using Fredericia’s formula.
- Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#11) listed below.
- For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.
- History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months.
- Ongoing serious, non-healing wound, ulcer, or bone fracture.
- History of reversible posterior leukoencephalopathy syndrome (RPLS).
- History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05848739
Principal Investigator
Marjorie Zauderer, MD
Contact for Study Screening
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Eligibility
- Male or Female, 21 years of age or younger.
- Newly diagnosed PPB. Note that patients with known germline DICER1 variant or mosaicism with a large, solid unresectable thoracic mass with imaging features characteristic for Type II or III PPB are eligible without histologic confirmation of the diagnosis if a biopsy of the mass is not considered safe or feasible.
- Individuals are eligible based on institutional diagnosis of Type I, Ir, II or III PPB diagnosed within 60 days prior to enrollment. Children with Type II or III PPB at risk for clinical decompensation may receive protocol therapy while awaiting rapid central pathology review. Children with Type I or Ir PPB will be assigned to chemotherapy vs. observation based on imaging and central pathology review diagnosis. Type I and Ir patients should not begin chemotherapy prior to return of central pathology results.
- Organ Function Requirements:
- There are no specific organ function requirements for patients with Type I or Ir PPB.
- For patients with Type II or III PPB (within 7 days prior to enrollment): A serum creatinine based on age/sex as follows:
- Age: 1 month to < 6 months – Maximum Serum Creatinine (mg/dL): 0.4 (Male), 0.4 (Female)
- Age: 6 months to < 1 year – Maximum Serum Creatinine (mg/dL): 0.5 (Male), 0.5 (Female)
- Age: 1 to < 2 years – Maximum Serum Creatinine (mg/dL): 0.6 (Male), 0.6 (Female)
- Age: 2 to < 6 years – Maximum Serum Creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
- Age: 6 to < 10 years – Maximum Serum Creatinine (mg/dL): 1 (Male), 1 (Female)
- Age: 10 to < 13 years – Maximum Serum Creatinine (mg/dL): 1.2 (Male), 1.2 (Female)
- Age: 13 to < 16 years – Maximum Serum Creatinine (mg/dL): 1.5 (Male), 1.4 (Female)
- Age: ≥ 16 years – Maximum Serum Creatinine (mg/dL): 1.7 (Male), 1.4 (Female) OR – A 24 hour urine creatinine clearance ≥ 60 mL/min/1.73 m^2 OR – A glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
- For patients with Type II or III PPB (within 7 days prior to enrollment): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- For patients with Type II or III PPB (within 7 days prior to enrollment): Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L.
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L - Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram (within 21 days prior to start of protocol therapy).
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4.
- Exclusion Criteria
- Administration of prior PPB-directed chemotherapy is an exclusion criterion. Prior treatment for another malignancy is not an exclusion criterion.
- Patients with known Charcot-Marie-Tooth disease.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
- All patients and/or their parents or legal guardians must sign a written informed consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06647953
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male or Female, < 30 years old at enrollment.
- Patients must be enrolled on APEC14B1 and consent to Part A – Eligibility Screening prior to enrollment on AREN2231.
- Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1.
- Patients must receive a qualifying Initial Stratum Assignment on APEC14B1 by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.
- Patients must enroll on AREN2231 by Day 14.
- Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or biopsy) without receiving an Initial Stratum Assignment on APEC14B1, patient will not be eligible for enrollment on AREN2231 unless all required materials (reports and Case Report Forms and specimens) for an Initial Stratum Assignment arrived by Day 7, but an Initial Stratum Assignment was not completed by Day 14. In these circumstances, after obtaining appropriate protocol consent, the patient may proceed with treatment according to local institutional staging and enroll within 5 calendar days of notification of the central Initial Stratum Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in agreement with any treatment already initiated. If the Initial Stratum Assignment is not in agreement with the local institution’s assessment then the patient will be ineligible for AREN2231.
- All sites must have sent or plan to send diagnostic tumor sample for molecular testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or equivalent if outside of the United States [US]) laboratory that can detect Loss of Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients potentially eligible for mVLR must also have LOH of chromosome 11p15 included.
- Note: Patients are eligible for enrollment before these results are available; however, molecular results must be returned and uploaded to APEC14B1 for integration into risk stratification by the required timepoints (specific timelines vary by treatment arm). Patients who do not have molecular results available by the arm-specific timepoints may be taken off protocol therapy.
- Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible.
- Note: Lymph node sampling will also be required at delayed nephrectomy. Patients who do not have a lymph node sampled and confirmed as a lymph node by central pathology review at delayed nephrectomy will be taken off protocol therapy.
- Karnofsky performance status must be 50 for patients > 16 years of age and the Lansky performance status must be 50 for patients ≤ 16 years of age.
- Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X ULN for subjects with total bilirubin levels > 1.5 ULN (within 7 days prior to enrollment)
- Aspartate aminotransferase (AST/serum glutamate oxaloacetic transaminase [SGOT]) OR alanine transaminase (ALT/serum glutamic pyruvate transaminase [SGPT]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).
- Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)
- Note: This criteria only applies to patients centrally classified as Stage IV. Stage II and III patients subsequently assigned to a doxorubicin arm will be off protocol therapy if they do not meet this criterion at time of cardiac function assessment.
- Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
- Exclusion Criteria
- Patient with a diagnosis of Stage V Bilateral Wilms Tumor.
- Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.
- Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.
- Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.
- Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor.
- Please note: Those with lung metastases as the only metastatic site who have complete resection of all radiologically evident lung nodules after enrollment but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable for lung assessment and subsequent stratum assignment and will, therefore, come Off Protocol Therapy.
- Patients who have had prior tumor-directed chemotherapy or radiotherapy for the current diagnosis except for therapy delivered for an emergent issue, as medically indicated.
- Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.
- Patients receiving concurrent chemotherapy for a different diagnosis.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06401330
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
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Eligibility
- Male or Female, 1 Month to 17 Years
- Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma
- Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Exclusion criteria:
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments
- Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
- Has a history of solid organ transplant
- Has a history of allogeneic stem cell transplant
- Has clinically significant corneal disease
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks
- Has uncontrolled or significant cardiovascular disorder
- Has uncontrolled or significant cardiovascular disorder
- Has a history of human immunodeficiency virus (HIV) infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 1 year
- Has an active infection requiring systemic therapy
- Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid [RNA]) infection
- Has not adequately recovered from major surgery or have ongoing surgical complications
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06941272
Principal Investigator
Andrew Bellantoni, MD
Contact for Study Screening
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Eligibility
- Male or female subjects ≥18 years old
2. Subjects must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not amenable for treatment with curative intent, e.g.:- Part 1:
- mesothelioma
- epithelioid hemangioendothelioma (EHE)
- cholangiocarcinoma (CCA)
- head and neck squamous cell carcinoma (HNSCC)
- non-small cell lung carcinoma (NSCLC)
- colorectal cancer (CRC)
- hepatocellular cancer (HCC)
- castration-resistant prostate cancer (CRPC)
- meningioma
- any other solid tumours with available local data for loss-of-function genetic alterations (truncating mutations or gene deletion) in neurofibrin 2 (NF2)/large tumour suppressor kinase (LATS1/LATS2), or Yes-associated protein/ Transiptional coactivator with PDZ-binding motif (YAP/TAZ) fusions
- any other solid tumour based on emerging scientific data as per sponsor’s decision.
- Part 2:
- Any solid tumour type harbouring a Hippo pathway alteration and other tumour types potentially responsive to transcriptional enhanced associate domain (TEAD) inhibition based on data from Part 1 or other existing or emerging scientific data.
- Part 1:
- Subjects must be in need of systemic treatment for their cancer and to either be refractory to or have progressed on, are intolerant to, or are not otherwise a candidate, in the opinion of the investigator, for any of the currently available established therapies (reasons of unsuitability of standard of care treatments to be recorded).
- Part 2 only: Subjects must have measurable disease by response evaluation criteria in solid tumours (response evaluation criteria in solid tumors – RECIST) v. 1.1 (modified RECIST for malignant pleural mesothelioma – MPM).
- Part 2 only: A fresh or recent (taken up to 1 year ago) primary tumour tissue sample from a diagnostic biopsy/surgery or a tumour biopsy taken from a metastasis must be available; exemptions possible by the sponsor’s decision.
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of >12 weeks.
- Willing and able to comply with all aspects of the protocol.
- Provide written informed consent (IC; or witness consent) prior to any study-specific screening procedures.
- Exclusion Criteria:
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the subject has completed curative therapy.
- Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before study drug administration, or any persistent unresolved toxicity from previous anti-cancer therapies of common terminology criteria for adverse events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). Luteinizing hormone releasing hormone (LHRH) agonists or antagonists are allowed as concomitant treatment.
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug administration. Radiopharmaceuticals (strontium, samarium) within less than 8 weeks before study drug administration.
- Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated with local therapy.
- Known human immunodeficiency virus (HIV) infection.
- Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) Ribonucleic acid (RNA). Pre-study testing for these pathogens is not required.
- Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).
- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses >10 mg/day prednisone or equivalent) within 2 weeks before study drug administration.
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.
- Use of other investigational medicinal products within 2 weeks or at least5 half-lives (whichever is longer) before study drug administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the subject, if taking part in the study. For drugs such as investigational monoclonal antibodies with half-lives >10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with ODM-212 may commence.
- Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 ms, a prolonged QTc interval (QTcF/B >470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTc interval.Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) <50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of study drug.
- Female subjects who are breastfeeding or pregnant at screening or baseline.
- A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06725758
Principal Investigator
Marjorie Zauderer, MD
Contact for Study Screening
- Male or female subjects ≥18 years old
Brain Tumors
-
Eligibility
- 1 month – 17 years of age at time of study entry
- Has a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
- Is a candidate to receive myelosuppressive chemotherapy
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04570423
Principal Investigator
Mitchell S. Cairo, MD
Contact for Study Screening
-
Eligibility
- Subject is between 1 year and 30 years of age
- Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04308330
Principal Investigator
Jeremy Rosenblum, MD
Contact for Study Screening
-
Eligibility
- Subject is between 3 years and 21 years of age
- Classical histologic type (non LC/A) WNT medulloblastoma that is Positive nuclear beta-catenin by immunohistochemistry (IHC), Positive for CTNNB1 mutation and Negative for MYC and MYCN by fluorescence in situ hybridization (FISH); negative CNS on lumbar puncture
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT02724579
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
Eligibility
- Subject is no more than 10 years of age
- Diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT02875314
Principal Investigator
Mitchell Cairo, MD
Contact for Study Screening
-
Eligibility
- Subject is between 2 and 21 years of age
- Neurofibromatosis type 1 (NF1)
- Newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
- Optic pathway gliomas
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT03871257
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
Eligibility
- Subject is between 2 and 21 years of age
- Non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation
- All tumors considered low-grade glioma or low-grade astrocytoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04166409
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
Eligibility
- Subject is between 2 and 25 years of age
- Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
- Progressive or recurrent LGG
- Metastatic disease or multiple independent primary LGGsl
- All tumors considered low-grade glioma or low-grade astrocytoma
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04576117
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
Eligibility
- Subject is between 3 and 30 years of age
- Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or greater than 10 ng/mL or human chorionic gonadotropin (hCG) beta greater than 100 mIU/mL
- Suprasellar, pineal and bifocal tumors are included
- Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04684368
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
-
Eligibility
- Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
- Willing and able to provide informed consent and to participate in all evaluations
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT04427384
Principal Investigator
Simon Hanft, MD
Contact for Study Screening
Sarcoma
-
Eligibility
- Patients must be ≤ 21 years at the time of enrollment.
- Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
- All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.
- Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
- Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.
- Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients ≥ 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.
- Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
- Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
- Exclusion Criteria
- Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
- Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
- Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
- Evidence of uncontrolled infection.
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05304585
Principal Investigator
Jessica Hochberg, MD
Contact for Study Screening
Mesothelioma
-
Eligibility
- Male or Female, Age ≥ 18 years at the time of screening.
- Histologically proven diagnosis of PM with known histology (epithelioid vs. non-epithelioid).
- Advanced unresectable disease that cannot be treated with surgery with curative intent (with or without chemotherapy).
- WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS > 1) over the previous 2 weeks prior to day of first dosing.
- Life expectancy ≥ 12 weeks
- Provision of existing (leftover) tumor sample obtained within 6 months prior to screening is required, if available.
- Measurable disease, per investigator assessment, defined as:
- Mesothelioma tumor thickness perpendicular to the chest wall or mediastinum, that can be measured in up to 2 positions at 3 separate levels on transverse cuts of CT scan (cuts must be at least 10 mm apart), for a total of up to 6 measurements. Each single tumor measurement must be at least 7 mm to qualify as measurable disease and contribute to the sum that defines the pleural measurement as per mRECIST 1.1 criteria.
- Non-pleural metastatic target lesions measured uni-dimensionally as per RECIST 1.1 criteria.
- Patients who present without pleural lesions that can be considered measurable, but with metastatic lesions (non-pleural) meeting criteria for target lesion by RECIST 1.1 criteria may be considered for inclusion, based upon the investigator’s judgment.
- Body weight > 35 kg
- Exclusion Criteria
- As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and adequate follow-up with no known active disease or have not required active treatment within the past 2 years before the first dose of study intervention and of low potential risk for recurrence.
- Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ, including Ta bladder tumors, without evidence of disease. Cancer participants with incidental histologic findings of prostate cancer that, in the opinion of the investigator, is not deemed to require active therapy (eg, incidental prostate cancer identified following cystoprostatectomy that is tumor/node/metastasis stage ≤ pT2N0) may be enrolled, pending discussion and approval by the investigator.
- Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (eg, colitis or Crohn’s disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, pneumonitis (past medical history of ILD, drug-induced ILD, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD), etc. The following are exceptions to this criterion:
- Participants with vitiligo or alopecia.
- Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
- Any chronic skin condition that does not require systemic therapy.
- Participants without active disease in the last 5 years prior to enrolment may be included.
- Participants with celiac disease controlled by diet alone.
- History of active primary immunodeficiency.
- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression. Participants with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry. The following participants can be included:
- Participants previously treated with radiation or surgical resection within 3 months prior to first dose of investigational products for CNS metastases who are asymptomatic, and clinically stable who do not require corticosteroids for at least 14 days prior to the first dose of investigational product.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06097728
Principal Investigator
Marjorie Zauderer, MD
Contact for Study Screening
Non-Small-Cell Lung
-
Eligibility
- Male or Female, Age ≥ 18 years at the time of screening.
- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition].
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention.
- Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible.
- Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]).
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- Exclusion Criteria
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor.
- Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements.
- Received prior neoadjuvant therapy for their current NSCLC diagnosis.
- Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137).
- Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol.
- Received prior treatment with a cancer vaccine.
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06623422
Principal Investigator
Marjorie Zauderer, MD
Contact for Study Screening
-
Eligibility
- Male or Female, Age ≥ 18 years
- Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
- Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
- Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
- Participants must have a life expectancy of at least 3 months at the time of randomization.
- Exclusion Criteria
- Participants must not be pregnant and/or breastfeeding.
- Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
- Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- Participants must not have concurrent malignancy requiring treatment.
- Participants must not have an active autoimmune disease.
- Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.
- Participants must not have a history of myocarditis.
- Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06561386
Principal Investigator
Marjorie Zauderer, MD
Contact for Study Screening