Zanzalintinib + Etoposide for Germ Cell Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of drugs, zanzalintinib and etoposide, to treat germ cell cancer that has returned or resisted other treatments. Researchers aim to determine if this combination can help when standard therapies are no longer effective. The trial is suitable for individuals whose germ cell cancer has recurred after initial treatments and who have already undergone high-dose chemotherapy and stem cell transplants. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like oral anticoagulants or complementary medicines within 2 weeks before starting the study treatment. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that zanzalintinib, a main treatment in this trial, was tested previously and found safe for humans. It targets specific proteins that aid cancer growth. In earlier studies, most participants tolerated zanzalintinib well, experiencing no severe side effects.
Etoposide, already approved by the FDA for certain cancers, has a well-understood safety profile. Doctors are familiar with its possible side effects and how to manage them.
Overall, both treatments have demonstrated safety in humans, but side effects may still occur. Trial participants will receive close monitoring to ensure their safety.12345Why are researchers excited about this trial's treatments?
Most treatments for germ cell cancer, like chemotherapy with cisplatin, attack fast-growing cells. But Zanzalintinib is unique because it targets specific pathways in cancer cells, potentially reducing harm to healthy cells. Researchers are excited about combining Zanzalintinib with Etoposide because it could enhance the effectiveness of standard treatments, offering better outcomes with possibly fewer side effects. This targeted approach represents a promising shift from traditional methods, aiming to improve both survival rates and quality of life for patients.
What evidence suggests that this trial's treatments could be effective for germ cell cancer?
Research has shown that combining zanzalintinib with etoposide might improve treatment outcomes for germ cell cancer. Etoposide is already effective against certain cancers. In other studies, zanzalintinib combined with nivolumab helped shrink tumors in 63% of patients and controlled the disease in 90% of them. This trial will specifically explore the combination of zanzalintinib and etoposide for germ cell cancer. Although data on this combination remains limited, these findings are promising.12678
Who Is on the Research Team?
Jennifer King, MD
Principal Investigator
Indiana University Simon Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults (≥18 years) with relapsed germ cell tumors after initial cisplatin-based chemotherapy, who've completed salvage treatment with high-dose chemotherapy and stem cell transplant. They must have adequate organ function, no severe recent illnesses or conditions that could interfere with the trial, not be pregnant or breastfeeding, and agree to use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Dose Escalation
Evaluation of three doses of zanzalintinib for toxicity in combination with oral etoposide
Phase II Dose Expansion
Maintenance treatment with zanzalintinib and etoposide until progression or toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Etoposide
- Zanzalintinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD