Pumitamig + Ipilimumab/Cabozantinib for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new treatment, Pumitamig, for people with advanced kidney cancer. Researchers are testing Pumitamig alone and in combination with Ipilimumab (an immunotherapy drug) and Cabozantinib (a targeted therapy drug) to evaluate their effectiveness. The trial seeks participants with advanced kidney cancer that hasn't been treated with certain drugs and is not suitable for surgery or radiation. 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 treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take certain medications like corticosteroids or other immunosuppressive drugs within 14 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Cabozantinib is generally well-tolerated by patients with advanced kidney cancer. Studies indicate it has an acceptable safety profile, meaning most side effects can be managed. Adjusting the dosage or treatment schedule can help control these side effects without affecting the results.
When combined with nivolumab, Ipilimumab has demonstrated long-term safety for patients with advanced kidney cancer. This combination has not revealed any new safety concerns, and any serious side effects are usually known and treatable.
Regarding Pumitamig, less information is available about its safety in humans because it is still under study. As it is in early clinical trials, its safety is being closely monitored. There might be unknown risks, but identifying these risks is part of the trial's objectives.
Overall, Cabozantinib and Ipilimumab are considered fairly safe with manageable side effects, while Pumitamig's safety is still being evaluated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Pumitamig combined with Ipilimumab and Cabozantinib for kidney cancer because it represents a novel approach compared to existing treatments. Most current therapies, like sunitinib or pazopanib, primarily inhibit tumor growth via blocking specific growth factors. However, Pumitamig offers a new mechanism of action by targeting different pathways that could enhance the immune system’s ability to fight cancer. This combination therapy aims to tackle cancer more comprehensively by not only halting tumor growth but also boosting immune response, which could potentially lead to more effective outcomes for patients.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
Research has shown that Cabozantinib, one of the treatments in this trial, performs well for advanced kidney cancer, yielding better-than-expected results and longer survival times. Specifically, patients treated with Cabozantinib in studies lived for a median of 46.5 months. Ipilimumab, another treatment option in this trial, provides significant survival benefits when combined with other treatments for advanced kidney cancer, helping patients live longer compared to some other treatments. Pumitamig, also under study in this trial, is a newer treatment. Early data shows a 76.3% response rate and noticeable tumor shrinkage in patients. These findings suggest that these treatments could be promising options for kidney cancer.678910
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with advanced Renal Cell Carcinoma (RCC), also known as kidney cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis of RCC.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pumitamig alone or in combination with Ipilimumab or Cabozantinib
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cabozantinib
- Ipilimumab
- Pumitamig
Trial Overview
The study is testing the safety and effectiveness of Pumitamig on its own or when used together with either Ipilimumab or Cabozantinib in treating advanced RCC. The trial may include comparisons between these combinations to find out which works best.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Citations
Efficacy and Safety of Cabozantinib in Patients with ...
A multicenter retrospective study was conducted to evaluate the efficacy and safety of cabozantinib in patients with advanced or metastatic renal cell ...
Real-world study of cabozantinib treatment of advanced ...
The 5-year survival rate for metastatic kidney cancer is poor (15 % in 2021 in the USA) [1,6]. Cabozantinib is an oral inhibitor of multiple ...
Nivolumab Plus Cabozantinib Continues to Show Superior ...
With a median follow-up of 67.6 months, final results from the phase III CheckMate 9ER trial showed a median overall survival of 46.5 months for ...
Cabozantinib outcomes for metastatic renal cell carcinoma ...
Conclusions: Overall, Cabozantinib showed better than expected response rates, and the toxicities in our NHS tertiary hospital were less severe ...
Real-World Outcomes in Patients With Metastatic Renal ...
This study provides data to support the understanding of the real-world utilization and long-term effectiveness of 1L NIVO + IPI in patients ...
Management of Adverse Events Associated with ...
This review reports on the safety profile of cabozantinib in patients with advanced renal cell carcinoma and offers guidance on the management of adverse ...
Activity and Safety of Cabozantinib for Brain Metastases in ...
These findings show considerable intracranial activity and an acceptable safety profile of cabozantinib in patients with renal cell carcinoma and brain ...
Safety and Efficacy of Cabozantinib in Metastatic Renal- ...
Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
Real-life Use of Cabozantinib in Front-line therapy for ...
We found that cabozantinib is active and safe, and that changes in the dose or treatment schedule because of side effects do not affect outcomes. Cabozantinib ...
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clinical-genitourinary-cancer.com
clinical-genitourinary-cancer.com/article/S1558-7673(23)00217-3/fulltextReal-World Results of Cabozantinib Given as Alternative ...
Safety and efficacy of cabozantinib in real world is comparable to what has been observed in the pivotal trials, irrespective of the treatment ...
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