Zanzalintinib + Ipilimumab + Nivolumab for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of drugs—zanzalintinib, ipilimumab, and nivolumab—to determine their effectiveness for certain types of advanced soft tissue sarcoma, a cancer that begins in the body's soft tissues. The main goal is to assess whether this drug combination is safe and could serve as a potential treatment option. Individuals with a type of soft tissue sarcoma that has spread or cannot be surgically removed, and who have tried one to three other treatments without success, may qualify for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug combination.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications, like small molecule kinase inhibitors and some anticoagulants, must be stopped before starting the trial. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining zanzalintinib with ipilimumab and nivolumab might be safe. Although detailed safety information is not yet available, this trial is in an early stage. Researchers are still determining the best dose and monitoring for any side effects.
Nivolumab and ipilimumab are already used together for other conditions and are generally safe, though some people might experience fatigue or skin issues. Zanzalintinib is less familiar, and researchers are testing its effectiveness with the other two drugs.
As this is an early-phase study, safety remains a major focus. Researchers will closely monitor participants to quickly address any problems. Prospective participants should know that the team prioritizes safety while learning more about this treatment combination.12345Why are researchers excited about this trial's treatments?
Unlike standard chemotherapy or radiation therapies for soft tissue sarcoma, the combination of Zanzalintinib, Ipilimumab, and Nivolumab offers a unique approach by harnessing the power of the immune system. Most current treatments focus on directly attacking cancer cells, but this combination aims to boost the body's own immune response to fight the cancer. Zanzalintinib is a promising new tyrosine kinase inhibitor that targets specific pathways to potentially inhibit tumor growth, while Ipilimumab and Nivolumab are immune checkpoint inhibitors that help the immune system recognize and destroy cancer cells more effectively. Researchers are excited because this could offer a more targeted and potentially less toxic alternative, with the potential for longer-lasting effects.
What evidence suggests that this trial's treatments could be effective for metastatic soft tissue sarcoma?
This trial will evaluate the combination of zanzalintinib, ipilimumab, and nivolumab for treating advanced soft tissue sarcoma. Research has shown that using zanzalintinib with nivolumab led to a 63% objective response rate, with many patients experiencing tumor shrinkage. Additionally, 90% of patients achieved stable disease or better, indicating effective disease control. Previous studies found that adding ipilimumab to nivolumab improved response rates compared to nivolumab alone. These drug combinations could offer new hope for patients facing this challenging condition.13467
Who Is on the Research Team?
Mia Weiss, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with metastatic soft tissue sarcoma who've had 1-3 prior treatments (except alveolar soft part sarcoma patients). They must have progressing disease, not be pregnant, agree to contraception, and have good performance status. Exclusions include heart issues, certain other cancers or therapies recently received, autoimmune diseases, major surgery within a specific timeframe, and inability to swallow pills.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Zanzalintinib, Nivolumab, and Ipilimumab. Zanzalintinib is self-administered daily, while Nivolumab and Ipilimumab are administered intravenously every 3 weeks for 4 doses. After 4 cycles, Ipilimumab is discontinued, and Nivolumab is continued every 4 weeks with daily Zanzalintinib.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and objective response rate.
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Zanzalintinib
Trial Overview
The study tests the combination of Zanzalintinib with Ipilimumab and Nivolumab in treating metastatic soft tissue sarcomas. It aims to determine if this drug combo is safe and effective as a new treatment strategy for these cancer types.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Zanzalintinib dose determined in Dose Escalation by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
Zanzalintinib 60 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
Zanzalintinib 40 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
Zanzalintinib 20 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
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
Citations
NCT06968988 | Zanzalintinib in Combination With ...
The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/52fca5e88f4692cc/nct06968988-zanzalintinib-ipilimumab-nivolumab-metastatic-sarcomaZanzalintinib in Combination With Ipilimumab and Nivolumab ...
The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic ...
Zanzalintinib + Ipilimumab + Nivolumab for Soft Tissue ...
The study tests the combination of Zanzalintinib with Ipilimumab and Nivolumab in treating metastatic soft tissue sarcomas.
4.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-phase-1b2-stellar-002Press Release - Exelixis, Inc.
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90%.
Novel Insights into the Immunotherapy of Soft Tissue ...
In this study, only 5% of the patients receiving nivolumab responded to the treatment whereas addition of ipilimumab to nivolumab therapy led to an increased ...
Zanzalintinib in Combination With Ipilimumab and ...
The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic ...
Zanzalintinib in Combination With Ipilimumab and ...
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma ... Download Trial Data.
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