Study on Immunotherapy with Nivolumab and Ipilimumab, Followed by Nivolumab or Nivolumab with Cabozantinib for Advanced Kidney Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03793166
This clinical trial is exploring whether adding the drug cabozantinib to the usual immunotherapy treatment can improve outcomes for patients with advanced kidney cancer that has spread. The study compares the standard treatment of nivolumab and ipilimumab followed by nivolumab alone, to the same initial treatment followed by nivolumab with cabozantinib.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding cabozantinib to the usual immunotherapy treatment of nivolumab and ipilimumab can better control advanced kidney cancer that has spread to other parts of the body. Immunotherapy drugs like nivolumab and ipilimumab help the immune system attack cancer cells, while cabozantinib may block enzymes that help cancer cells grow. This study aims to find out if this combination can improve survival and control the disease more effectively.
Description
This study is divided into two main parts: the initial treatment phase and the follow-up treatment phase.
Initial Treatment Phase:
- All participants will receive nivolumab and ipilimumab through an IV infusion every 21 days for up to 4 cycles, as long as the cancer does not progress or cause unacceptable side effects.
Follow-Up Treatment Phase:
- Participants whose cancer shows signs of progression but are stable will receive cabozantinib orally every day.
- Participants whose cancer is stable or improving will be randomly assigned to one of two groups:
- Group A: Continue receiving nivolumab through an IV infusion every 28 days.
- Group B: Receive both nivolumab through an IV infusion and cabozantinib orally every day.
Throughout the study, participants will undergo regular scans and tests to monitor their cancer and overall health. The study aims to compare survival rates, cancer progression, and quality of life between the two treatment groups.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced kidney cancer with a clear cell component.
- Cancer has spread to other parts of the body and is measurable by scans.
- Must meet certain health criteria, such as a performance status score of 70% or higher.
- No prior treatment with specific immunotherapy drugs targeting PD-1, PD-L1, or CTLA-4, except under certain conditions.
- No recent cancer treatments or major surgeries within specified timeframes.
- Not pregnant or nursing, and willing to use effective contraception if of childbearing potential.
- No active autoimmune diseases requiring treatment, severe allergies to study drugs, or uncontrolled health conditions.
- Adequate blood counts and organ function as determined by specific tests.
- Must have completed at least one cycle of the initial treatment and resolved any treatment-related side effects to a manageable level.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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