Durvalumab + Tremelimumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two immunotherapy drugs, durvalumab and tremelimumab, for their effectiveness in treating ovarian, primary peritoneal, or fallopian tube cancer that has returned or isn't responding to other treatments. These drugs aim to help the body's immune system target and attack cancer cells. The trial explores whether administering these drugs together or sequentially is more effective. Participants who might be a good fit have these types of cancer that have stopped responding to platinum-based treatments and have measurable disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications to join the trial?
The trial requires that you have not received any anti-cancer therapy within 28 days before starting the study drugs, and you must not use immunosuppressive medication within 28 days before the first dose, except for certain low-dose corticosteroids. If you're on other medications, the protocol does not specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining durvalumab and tremelimumab is generally safe for patients with various solid cancers. Studies have found that this combination has a manageable safety profile. Serious side effects can occur, but they are uncommon. For example, in some studies, about 8% of patients experienced severe reactions, with only a small number of deaths directly related to the treatment.
When administered sequentially, the safety of these drugs remains similar. Both durvalumab and tremelimumab are considered safe for cancer patients, with side effects comparable to those seen when used together.
While side effects are possible, the potential benefits in treating certain cancers often outweigh them. Prospective trial participants should discuss potential risks and benefits with their doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of durvalumab and tremelimumab for ovarian cancer because these drugs work by harnessing the body's immune system to fight cancer, a method known as immunotherapy. Unlike traditional chemotherapy, which attacks cancer cells directly, these treatments target immune checkpoints like CTLA-4 and PD-L1, potentially leading to a more targeted immune response against the cancer. This approach could offer a new avenue of hope for patients, especially those who may not respond well to existing treatments like surgery and chemotherapy. Additionally, the combination therapy may enhance the effectiveness of the immune response compared to using either drug alone.
What evidence suggests that durvalumab and tremelimumab might be effective treatments for ovarian cancer?
Research shows that combining durvalumab and tremelimumab may help treat various cancers by enhancing the immune system's ability to attack tumors. In studies on other cancers, such as liver cancer, this combination has been linked to improved survival rates. These drugs work by blocking proteins that usually prevent the immune system from effectively fighting cancer cells. In this trial, participants will receive either a combination of tremelimumab and durvalumab or a sequential treatment of these drugs. While research on ovarian cancer continues, the drugs have shown promise in other cancers, suggesting potential benefits here as well. Early results indicate these drugs could slow the growth of cancer cells.26789
Who Is on the Research Team?
Amir A. Jazaeri
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with recurrent or resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants must be over 18 years old, have a good performance status (able to carry out daily activities), and have proper organ function. They should not be pregnant and must use effective birth control if of reproductive potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Sequential Arm)
Participants receive tremelimumab IV every 4 weeks for 4 cycles, followed by durvalumab IV every 4 weeks for up to 9 cycles upon progression
Treatment (Combination Arm)
Participants receive tremelimumab and durvalumab IV every 4 weeks for 4 cycles, followed by durvalumab IV every 4 weeks for up to 9 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor