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New treatment option for Germ Cell Tumor
Official title Maintenance Zanzalintinib With Etoposide After HDCT in GCT
ClinicalTrials.gov ID: NCT06937866
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for germ cell tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase I:
- Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women...
- Must have received initial cisplatin-based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced...
- people with relapsed primary mediastinal non-seminomatous germ-cell tumor (PMNSGCT) or late relapse (\>2 years) not amenable to resection are...
- Histological or serological evidence of non-seminomatous GCT
You likely can't join if
- Phase I: 1\. Patients who have not received greater than or equal to 1 salvage treatment regimens or have further potentially curative treatment...
- Relapsed pure seminoma
- Rising tumor markers (AFP and hCG) at time of screening per discretion of treating physician
- Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \> 16 weeks ago For All Patients:
- Prior treatment with zanzalintinib
- Receipt of any type of cytotoxic, small molecule kinase inhibitor, biologic, investigational, or other systemic anticancer therapy (including...
See the full eligibility criteria
Who can join
- Phase I:
- Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
- 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...
- people with relapsed primary mediastinal non-seminomatous germ-cell tumor (PMNSGCT) or late relapse (\>2 years) not amenable to resection are eligible if they have received first line platinum-based chemotherapy and are...
- Histological or serological evidence of non-seminomatous GCT
- Relapsed disease after first-line cisplatin-based combination chemotherapy
- Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
- HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 4.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens including VeIP...
- Normal or declining tumor markers (AFP and hCG) at time of screening per discretion of treating physician. Patients need to be considered disease free with no known active residual GCT.
- Last dose of HDCT must be ≤ 16 weeks from study registration
- Women with ovarian germ cell tumors are eligible For All Patients:
- Written informed consent and HIPAA authorization for release of personal health information.
- Capable of understanding and complying with the protocol requirements.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days of study registration
- Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (eg, physiological replacement of...
- Adequate laboratory values obtained within 14 days prior to registration for protocol therapy and as defined below: 6.1. Hemoglobin ≥ 9g/dL 6.2. WBC ≥ 2500/µL 6.3. Absolute neutrophil count ≥ 1500/mm3 6.4. Platelet...
- Sexually active fertile people and their partners must agree to use highly effective method of contraception (defined in Appendix II) during the course of the study and for the following durations after the last dose of...
- through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men,
- through 180 days for women of childbearing potential (WOCBP) or through 120 days after the last dose of etoposide for men
- Female people of childbearing potential must not be pregnant at screening. Female people are considered to be of childbearing potential, and will need a negative pregnancy test, unless one of the following criteria is...
What rules you out
- 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:
- Relapsed pure seminoma
- Rising tumor markers (AFP and hCG) at time of screening per discretion of treating physician
- Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \> 16 weeks ago For All Patients:
- Prior treatment with zanzalintinib
- 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.
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study...
- Prior hypersensitivity to etoposide which did not recover with supportive care
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible...
- Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel). Note: people must have discontinued oral anticoagulants within 3 days or 5...
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in people without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week...
- Prior active malignancy is NOT allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast, or prostate cancer, superficial bladder cancer, Gleason \< Grade 7 and ≤ T2N0M0...
- History of psychiatric illness or social situations that would limit compliance with study requirements.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: 9.1. Unstable or deteriorating cardiovascular disorders: 9.1.1. Congestive heart failure...
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study...
- Symptomatic cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation (asymptomatic or radiated lesions allowed).
- Lesions invading or encasing any major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: people with intravascular tumor extension (eg, tumor thrombus in renal vein or...
- Other clinically significant disorders that would preclude safe study participation. 13.1. Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral)...
- Major surgery (as defined in Appendix B; eg GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Prior laparascopic surgeries (ie, nephrectomy) within 4 weeks prior to...
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 14 days of study registration. Note: If a single ECG shows a QTcF with an absolute value \> 500 ms, two...
- Pregnant or lactating females.
- Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Prior history of myocarditis.
- Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
- Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.