Germ Cell TumorPhase 2NCT04876456
A Phase II Trial of Cabozantinib With Patients With Refractory GCTs
A Phase 2 study testing Cabozantinib in people with Germ Cell Tumor and Seminoma, run by Jennifer King at 1 site in United States.
Trial summary
The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Germ Cell Tumor, Seminoma, Non-seminomatous Germ Cell Tumor
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Histological or serological evidence of germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
- Must have progressed after first-line cisplatin based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ cell and now considered incurable with standard therapies, including further chemotherapy or surgery.
- 5.1. "Failure" of prior therapy is defined as: 5.1.1. A >25% increase in the products of the perpendicular diameters of measurable tumor masses during prior therapy which are not amenable to surgical resection.
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- 5.1.2. The presence of new tumors that are not amenable to surgical resection 5.1.3. 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: Subjects with clinically growing teratoma (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery.
- Subjects with relapsed primary mediastinal non-seminomatous germ cell tumor (PMNSGCT) are eligible
- Subjects with late relapse (>2 years from previous chemotherapy) not amenable to resection are eligible if they have received first line platinum based chemotherapy and are deemed not amenable to surgical resection (no need for 1 salvage regimen in late relapse patients to be eligible).
- Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate laboratory values obtained within 10 days prior to registration for protocol therapy and as defined below:
- 10.1. Hemoglobin ≥9g/dL 10.2. WBC ≥2500/μL 10.3. Absolute neutrophil count ≥1500/mm3 10.4. Platelet count ≥100,000/mm3 10.5. Total bilirubin ≤1.5 X ULN except patients with documented Gilbert's syndrome (≤3 X ULN) 10.6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3 X ULN; for patients with hepatic metastases, ALT and AST ≤5 X ULN; ALP ≤5 X ULN with documented bone metastases.
- 10.7. Serum albumin ≥ 2.8 g/dl 10.8. (PT)/INR or partial thromboplastin time (PTT) test < 1.5x the laboratory ULN
- This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or direct factor Xa inhibitors) should be on a stable dose.
- 10.9. Serum creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 30 mL/min (≥ 0.5 mL/sec) using the Cockcroft-Gault equation:
- Males: (140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72) b. Females: [(140 - age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85 10.10. Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g
- Female patients of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Prior treatment with Cabozantinib.
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
- Subjects who have not received ≥1 salvage treatment regimens (except late relapse) or have further potentially curative treatment options.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks prior to first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic at the time of first dose of study treatment.
- Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to first dose of study treatment.
- Expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
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- Treatment with investigational agent, any type of cytotoxic, biologic or other systematic anticancer therapy within 28 days prior to registration for protocol therapy.
- Subjects with another active malignancy is not allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < Grade 7 prostate cancers, or other cancer for which the subject has not required therapy for ≥1 year.
- 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:
- 10.1 Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
- Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.
- 10.c.1 Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation for at least 1 week before first dose of study treatment.
- 10.2 Gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation:
- The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute Protocol Version Date: 03/08/2022 Page 17 obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.
- Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
- 11. 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 treatment.
- 12. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- 13. Lesions invading or encasing any major blood vessels. 14. Other clinically significant disorders that would preclude safe study participation per the investigator's opinion.
- Serious non-healing wound/ulcer/bone fracture. b. Uncompensated/symptomatic hypothyroidism. c. Moderate to severe hepatic impairment (Child-Pugh B or C). 15. Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
- 16. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment.
- Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
- 17. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
- 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 subjects who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
- 18. Pregnant or lactating females. 19. Inability to swallow tablets. 20. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase II Trial Evaluating the Efficacy of Cabozantinib in the Treatment of Incurable Patients With Refractory Germ Cell Tumors
The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.
- Being tested
- Cabozantinib
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Seminoma, Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.
| Study group | Role | What they receive |
|---|---|---|
| Cabozantinib | Experimental | Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure. Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
determined by the proportion of complete responses, partial responses, and stable disease for at least 3 months of therapy using RECIST 1.1 while including markers AFP/ beta-hcg.
Measured: Start of the treatment until time of death or last follow up visit (up to 2 years)
Secondary outcomes (4)
Objective response rate
Defined by proportion of complete response and partial response using RECIST 1.1 or tumor markers.
Measured: Start of the treatment until time of death or last follow up visit (up to 2 years)
Overall survival
Measured by start of the treatment until time of death or last follow up visit.
Measured: Start of the treatment until time of death or last follow up visit (up to 2 years)
Incidence of Adverse Events
Toxicity measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and need for treatment delay, dose reduction, or early discontinuation.
Measured: Start of treatment until end of treatment safety assessments (up to 2 year)
Progression free survival
The start of the treatment until death or criteria for disease progression are met. Patients who are event-free (death or progression) at the time of data analysis will be censored at their last date of contact.
Measured: Start of the treatment until time of death or last follow up visit (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 Jun 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer King
- Sponsor type
- University, hospital or other
- Collaborators
- Exelixis, JDS Foundation Testis Cancer Clinical Trials Support Fund
- Responsible party
- Sponsor-investigator, Jennifer King, Indiana University
- Investigators
- Jennifer King, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876456
- Sponsor's protocol ID
- CTO-IUSCCC-0752
- Status last verified
- Oct 2026
- First submitted
- 3 May 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating the Efficacy of Cabozantinib in the Treatment of Incurable Patients With Refractory Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT04876456
- Acronym / sponsor ID
- CTO-IUSCCC-0752
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jennifer KingUniversity, hospital or other
- Collaborators
- Exelixis, JDS Foundation Testis Cancer Clinical Trials Support Fund
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib | Experimental | Drug: CabozantinibPatients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- Histological or serological evidence of germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
- Must have progressed after first-line cisplatin based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ cell and now considered incurable with standard therapies, including further chemotherapy or surgery.
Key exclusion criteria (29 listed)
- Prior treatment with Cabozantinib.
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
- Subjects who have not received ≥1 salvage treatment regimens (except late relapse) or have further potentially curative treatment options.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks prior to first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic at the time of first dose of study treatment.
- Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibPatients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure. | Drug | Cabozantinib |
Primary outcome
Clinical benefit rate
Time frame: Start of the treatment until time of death or last follow up visit (up to 2 years)
determined by the proportion of complete responses, partial responses, and stable disease for at least 3 months of therapy using RECIST 1.1 while including markers AFP/ beta-hcg.
4 secondary outcomes
Objective response rate
Time frame: Start of the treatment until time of death or last follow up visit (up to 2 years)
Overall survival
Time frame: Start of the treatment until time of death or last follow up visit (up to 2 years)
Incidence of Adverse Events
Time frame: Start of treatment until end of treatment safety assessments (up to 2 year)
Progression free survival
Time frame: Start of the treatment until time of death or last follow up visit (up to 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer King, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Germ Cell Tumor and Seminoma, run by Jennifer King at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit rate (time frame: Start of the treatment until time of death or last follow up visit (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.