Study on Nivolumab and Ipilimumab for Treating Patients with Rare Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02834013
This clinical trial is exploring the use of two immunotherapy drugs, nivolumab and ipilimumab, to treat patients with rare types of tumors. These drugs may help the immune system attack cancer cells and prevent them from growing and spreading.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is testing the effectiveness of two immunotherapy drugs, nivolumab and ipilimumab, in treating patients with rare tumors. Immunotherapy uses the body's immune system to fight cancer. The trial includes different groups of patients based on their specific type of rare tumor. Some of these groups are no longer accepting new participants. The study aims to see if these drugs can help shrink tumors and improve survival rates in patients with these rare cancers.
Description
The main goals of this study are to see how well the combination of nivolumab and ipilimumab works in shrinking tumors in patients with rare cancers and to evaluate the safety of these drugs. The study will also look at how long patients live without their cancer getting worse and how long they survive overall.
Patients in the study will be divided into two groups:
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Group 1 (All Cohorts Except PD-L1 Amplified Cohort): Patients will receive nivolumab and ipilimumab through an IV. This treatment will be given every 42 days for up to 17 cycles (about 2 years), as long as the cancer does not progress and there are no severe side effects. After completing 17 cycles, patients may continue treatment with nivolumab alone every 2 or 4 weeks.
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Group 2 (PD-L1 Amplified Cohort): Patients will receive nivolumab through an IV every 42 days for up to 17 cycles. After completing 17 cycles, they may continue treatment with nivolumab every 2 or 4 weeks.
Throughout the study, patients will have regular check-ups, including heart tests (ECHO), MRI or CT scans, and blood tests to monitor their health and the effects of the treatment.
After finishing the study treatment, patients will be followed up for 10 years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of a rare cancer or gestational trophoblastic disease (GTD) and be able to provide necessary medical samples.
- For the PD-L1 amplified cohort, patients must have a solid tumor with PD-L1 amplification confirmed by specific lab tests.
- Must have tried at least one standard treatment that did not work or have no other standard treatment options available.
- Must have a recent CT or MRI scan showing measurable disease.
- Must not have any other active cancer, except for certain early-stage cancers that are in remission.
- Must be 18 years or older and have a good performance status (able to carry out daily activities).
- Must have adequate blood counts and organ function based on recent lab tests.
- Women of childbearing potential must not be pregnant and must agree to use effective birth control during the study and for a specified time after.
- Men must agree to use birth control during the study and for a specified time after.
- Must not have active hepatitis B or C, or HIV unless well-controlled.
- Must not have active autoimmune disease requiring treatment in the past 2 years.
- Must not have any uncontrolled medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| 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 |
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