Study Comparing Standard Treatment with a Combination of Targeted Immunotherapy Drugs for Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04739800
This clinical trial is exploring whether a combination of three targeted immunotherapy drugs—durvalumab, olaparib, and cediranib—can be more effective than the usual treatment for patients with ovarian, primary peritoneal, or fallopian tube cancer that has returned after initial improvement with platinum-based therapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if using different combinations of the drugs durvalumab, olaparib, and cediranib can help control ovarian, primary peritoneal, or fallopian tube cancer that has come back after treatment. These drugs work by helping the immune system attack cancer cells and preventing cancer cells from repairing themselves. The trial will compare these new combinations to the standard treatment usually given to patients with this type of cancer.
Description
The main goal of this study is to see if the combinations of durvalumab, olaparib, and cediranib can help patients live longer without their cancer getting worse, compared to the usual chemotherapy treatment. The study will also look at how well these combinations work in shrinking tumors and improving overall survival.
Participants will be randomly assigned to one of four groups:
- Group 1: Standard chemotherapy treatment, which may include drugs like paclitaxel, doxorubicin, or topotecan, given through an IV. Treatment cycles repeat every 21 or 28 days.
- Group 2: Durvalumab given through an IV, with cediranib and olaparib taken as pills. Treatment cycles repeat every 28 days.
- Group 3: Durvalumab given through an IV and cediranib taken as a pill. Treatment cycles repeat every 28 days.
- Group 4: Cediranib and olaparib taken as pills. Treatment cycles repeat every 28 days.
Throughout the study, participants will have regular blood tests and scans to monitor their health and the cancer's response to treatment. After completing the study treatment, participants will be followed up periodically for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Women with ovarian, primary peritoneal, or fallopian tube cancer that has returned after platinum-based therapy.
- Cancer must be confirmed by lab tests and be of certain types, such as high-grade serous or clear cell carcinoma.
- Must have had at least two previous cancer treatments and prior use of bevacizumab.
- Must be in good overall health with a performance status score of 0, 1, or 2.
- Must have adequate blood cell counts and organ function.
- Must be able to swallow pills and have no digestive issues that would affect medication absorption.
- Women of childbearing potential must agree to use effective birth control during the study.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Cancer that did not respond to initial platinum-based chemotherapy.
- Rising CA-125 levels without measurable disease.
- Recent chemotherapy, investigational drugs, or radiotherapy within 3 weeks before the study.
- History of severe immune-related side effects from previous treatments.
- Current bowel obstruction or recent history of severe abdominal issues.
- Pregnant or breastfeeding women.
- Untreated brain metastases or significant heart conditions.
- Recent major surgery or evidence of bleeding disorders.
- Active infections like hepatitis B, hepatitis C, or HIV.
- Use of certain medications that could interfere with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| 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 |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
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