Botensilimab + Balstilimab for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies a combination of two drugs, botensilimab and balstilimab, to determine their effectiveness in treating high-risk kidney cancer before surgery. These drugs, a type of immunotherapy, boost the body's immune system to combat cancer cells. The trial seeks to establish the safety and efficacy of these drugs for patients whose kidney cancer has not spread. It seeks participants with non-metastatic kidney cancer who have a clear cell component and plan to undergo surgery to remove the affected kidney. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Is there any evidence suggesting that botensilimab and balstilimab are likely to be safe for humans?
Research on the cancer treatments botensilimab and balstilimab continues. This trial is in Phase 2, indicating that the treatment has already undergone basic safety testing in humans. The current focus is on assessing its safety and effectiveness in more detail.
Earlier studies with similar treatments have shown that most participants tolerated them well. Common side effects include fatigue and mild skin reactions. Serious side effects are rare, but the trial team will closely monitor participants to manage any issues.
As these treatments remain under study, trials like this one are crucial for understanding their safety and side effects. Participants will receive careful monitoring to ensure their well-being throughout the study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Botensilimab and Balstilimab for kidney cancer because these treatments offer a novel approach compared to the current standard of care, which typically involves surgery and targeted therapies like tyrosine kinase inhibitors. Botensilimab is unique because it is an antibody that targets T cells, potentially boosting the immune system's response against cancer cells. Balstilimab blocks PD-1, a protein that helps cancer hide from the immune system, making it easier for the body to attack the cancer. Together, these treatments could enhance the body's natural defenses against kidney cancer, offering a promising alternative to existing therapies.
What evidence suggests that botensilimab and balstilimab might be effective for kidney cancer?
This trial will evaluate the combination of botensilimab and balstilimab for treating high-risk kidney cancer. Studies have shown that this drug pair may effectively treat the condition, offering promising results and a manageable safety profile. This treatment employs monoclonal antibodies to help the immune system target cancer cells. Patients with similar conditions have tolerated this combination well, and it has shown encouraging results in improving survival rates. Although more research is needed, these early findings offer hope for its potential effectiveness in treating localized kidney cancer before surgery.678910
Who Is on the Research Team?
Adanma Anji Ayanambakkam Attanathi
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults (18+) with high-risk, non-metastatic clear cell kidney cancer who are healthy enough for surgery to remove the tumor. Participants must have good organ function and be able to undergo a nephrectomy. People with evidence of cancer spread or poor overall health cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive botensilimab and balstilimab intravenously over 30 minutes on specified days across 12 weeks
Surgery
Participants undergo nephrectomy 12-16 weeks from the initiation of neoadjuvant therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for up to 1 year post-nephrectomy
What Are the Treatments Tested in This Trial?
Interventions
- Balstilimab
- Botensilimab
Trial Overview
The study is testing two immunotherapy drugs, botensilimab and balstilimab, given before surgery to see if they are safe and effective in treating high-risk clear cell kidney cancer that hasn't spread. All participants will receive these drugs before their planned kidney surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive botensilimab IV over 30 minutes on day 1 of weeks 1 and 7 and balstilimab IV over 30 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity. Patients undergo nephrectomy 12-16 weeks from the initiation of neoadjuvant therapy. Additionally, patients undergo blood sample collection and CT throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Study Details | NCT07516366 | Testing the Safety and ...
This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell ...
Botensilimab plus balstilimab in relapsed/refractory ... - PMC
The combination of BOT plus BAL demonstrated a manageable safety profile ・ encouraging clinical activity was overall well tolerated ・ ...
Testing the Safety and Feasibility of Immunotherapy Drugs ...
Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and/or effective in treating patients with high-risk non-metastatic clear cell renal ...
Combination Immunotherapy for Kidney Cancer ...
Giving botensilimab and balstilimab may be more safe and effective than standard treatment for patients with advanced clear cell renal cell carcinoma. 6 ...
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This study aims to evaluate the effectiveness of botensilimab and balstilimab combination therapy, compared to the standard ipilimumab and nivolumab treatment, ...
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