Nemvaleukin + Pembrolizumab for Ovarian Cancer
(ARTISTRY-7 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for women with certain types of ovarian cancer that have not responded well to standard treatments. The study tests the effectiveness of combining two drugs, nemvaleukin (an experimental treatment) and pembrolizumab (also known as KEYTRUDA, an immunotherapy drug), against standard chemotherapy options. Women who have experienced a return or worsening of their ovarian, fallopian tube, or primary peritoneal cancer after responding to platinum-based treatments might be suitable candidates. The goal is to determine if these new treatments can slow the cancer more effectively than existing options. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that nemvaleukin, both alone and with pembrolizumab, has a well-understood safety profile. Researchers know its effects on people, and patients have generally tolerated it well. Over 800 patients have received treatment in various studies, and it has been found safe in these groups.
Pembrolizumab, already used for other cancers, has also been studied for safety in ovarian cancer. It has shown some effectiveness and has been used in many trials, suggesting it is relatively safe for humans.
When used together, nemvaleukin and pembrolizumab show safety results consistent with previous studies, indicating the combination is tolerated without unexpected side effects. Although nemvaleukin hasn't shown a major benefit in extending life in some studies, it maintains a manageable safety profile.
In summary, both nemvaleukin and pembrolizumab, whether used separately or together, have been shown to be safe for human use in past research. They are well-tolerated, and any side effects are usually predictable and manageable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Nemvaleukin and Pembrolizumab for ovarian cancer because these treatments introduce innovative approaches compared to traditional chemotherapy options like paclitaxel or doxorubicin. Nemvaleukin, a novel interleukin-2 variant, is designed to selectively stimulate cancer-fighting immune cells without triggering regulatory cells that dampen the immune response. Pembrolizumab, a well-known checkpoint inhibitor, works by blocking a protein called PD-1, thereby reactivating the immune system to attack cancer cells. The combination of these two treatments aims to enhance the body's natural immune response, offering a potentially more targeted and effective approach against ovarian cancer than existing therapies.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research shows that nemvaleukin, a modified protein, has promising effects against tumors in patients with advanced solid cancers who have undergone many treatments. In this trial, some participants will receive nemvaleukin alone, while others will receive pembrolizumab alone. Pembrolizumab has shown benefits in treating various cancers, including ovarian cancer, and has improved survival rates in some studies. Additionally, one treatment arm will involve a combination of nemvaleukin and pembrolizumab. Recent studies found that this combination did not significantly improve survival in ovarian cancer patients. Although the combination treatment didn't meet all expectations, both treatments have shown potential individually in fighting cancer.23467
Who Is on the Research Team?
Mural Oncology Medical Monitor
Principal Investigator
Mural Oncology, Inc
Are You a Good Fit for This Trial?
This trial is for women over 18 with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. They must have seen their disease progress after recent therapy and received at least one line of bevacizumab-containing treatment. Excluded are those with certain subtypes of EOC, prior anti-PD1/PD-L1 therapy exposure, non-epithelial tumors, or significant fluid drainage needs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nemvaleukin and pembrolizumab combination therapy, pembrolizumab monotherapy, nemvaleukin monotherapy, or investigator's choice chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nemvaleukin
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alkermes, Inc.
Lead Sponsor
Richard Pops
Alkermes, Inc.
Chief Executive Officer since 1991
BA in Economics from Stanford University
Dr. Craig Hopkinson
Alkermes, Inc.
Chief Medical Officer since 2017
MD
Mural Oncology, Inc
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University