DFF332 + Combination Therapy for Renal Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called DFF332 in patients with advanced kidney cancer and other cancers with certain genetic mutations. The drug works by blocking a protein that helps the cancer grow.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain cancer treatments before starting the study. Specifically, you must not have had chemotherapy, biological therapy, or certain other cancer treatments within a few weeks before the trial begins. The protocol does not specify about other non-cancer medications, so it's best to discuss your current medications with the trial team.
What makes the drug DFF332 unique for treating renal cell carcinoma?
The drug DFF332 is unique for treating renal cell carcinoma because it is part of a combination therapy approach, which is a newer strategy in cancer treatment that aims to overcome resistance and improve survival by using multiple active agents together. This approach is different from traditional single-agent therapies and reflects the evolving treatment landscape for this condition.12345
What data supports the effectiveness of the drug combination DFF332, NIR178, PDR001, and RAD001 for renal cell carcinoma?
Research shows that combination therapies targeting immune checkpoints and specific growth factors have improved outcomes in advanced renal cell carcinoma, with some drugs like everolimus (similar to RAD001) extending survival in certain patients. This suggests that combining active agents, like those in the trial, could potentially enhance treatment effectiveness.12567
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced clear cell renal cancer (ccRCC) who've tried all standard treatments, including PD-1/L1 inhibitors and VEGF therapies. It's also open to those with certain genetic mutations or syndromes related to other cancers, as long as they have no remaining standard treatment options. People can't join if they have heart issues, uncontrolled illnesses like high blood pressure or infections, recent major surgery, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Initial evaluation of DFF332 as a single agent, followed by combination with Everolimus or Spartalizumab plus Taminadenant after two dose levels of single agent have been evaluated
Dose Expansion
Expansion of single agent and combination arms to further assess safety and efficacy in specific patient groups
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DFF332
- NIR178
- PDR001
- RAD001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD