Loading clinical trials...

Maintenance Zanzalintinib With Etoposide After HDCT in GCT | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Maintenance Zanzalintinib With Etoposide After HDCT in GCT

Maintenance Zanzalintinib With Oral Etoposide Following High-dose Chemotherapy in Patients With Relapsed Metastatic Germ-cell Tumor

NCT06937866•Indiana University

View on ClinicalTrials.gov

Summary

This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.

Detailed Description

This prospective, phase I/II trial will initially enroll 9 patients with relapsed, refractory metastatic disease. Two doses of zanzalintinib will be evaluated for toxicity. The patients will receive zanzalintinib orally daily continuously in combination with oral standard of care etoposide daily for 21 days out of 28 day cycles until time of progression or toxicity. The DLT period is 1 cycle of 28 days. We will employ the Bayesian optimal interval (BOIN) design to find the MTD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase I:
•1. Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
•2. Must have received initial cisplatin-based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ-cell neoplasm and now considered incurable with standard therapies, including further chemotherapy or surgery.
•2.1. "Failure" of prior therapy is defined as: 2.1.1.A \>25% increase in the products of the perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection.
•2.1.2.The presence of new tumors that are not amenable to surgical resection 2.1.3.An increase in AFP or beta-hcg (two separate determinations at least one week apart are required if rising tumor markers are the only evidence of failure).
•NOTE: Patients with clinically growing teratoma (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery.
•Phase II:
•1. Histological or serological evidence of non-seminomatous GCT
•2. Relapsed disease after first-line cisplatin-based combination chemotherapy
•3. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
+18 more criteria

Exclusion Criteria

•Phase I:
•1\. Patients who have not received greater than or equal to 1 salvage treatment regimens or have further potentially curative treatment options.
•Phase II:
•1. Relapsed pure seminoma
•2. Rising tumor markers (AFP and hCG) at time of screening per discretion of treating physician
•3. Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \> 16 weeks ago
•For All Patients:
•1. Prior treatment with zanzalintinib
•2. Receipt of any type of cytotoxic, small molecule kinase inhibitor, biologic, investigational, or other systemic anticancer therapy (including investigational) within 2 weeks before first dose of study treatment.
•4. Prior hypersensitivity to etoposide which did not recover with supportive care
+30 more criteria

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Key Dates

Start Date

November 12, 2025

Primary Completion Date

March 1, 2030

Completion Date

September 1, 2031

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Germ Cell Tumor

Interventions

Zanzalintinib

DRUG

Etoposide Capsule

DRUG

Contacts

Jennifer King, MD

CONTACT

317-948-0361 jmstrass@iu.edu

Christin Snow, RN

CONTACT

317-274-5830 chsnow@iu.edu

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

NCT03067181

Childhood Extracranial Germ Cell TumorExtragonadal Embryonal Carcinoma+28 more

View study

RECRUITINGPHASE1

Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

NCT07218913

Hearing LossMetastatic Malignant Germ Cell Tumor+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Maintenance Zanzalintinib With Etoposide After HDCT in GCT

Inclusion Criteria

Exclusion Criteria

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

Molecular Epidemiology of Pediatric Germ Cell Tumors

Treatment of Newly Diagnosed Central Malignant Germ Cell Tumor People With Teniposide Injection Combined With Cisplatin.

Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors