Nemvaleukin + Pembrolizumab for Ovarian Cancer

(ARTISTRY-7 Trial)

Recruiting in Palo Alto (17 mi)

+280 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alkermes, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Mural Oncology Medical Monitor

Principal Investigator

Mural Oncology, Inc

Eligibility Criteria

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

I am willing to have a biopsy or provide previous biopsy samples.

My cancer got worse or didn't respond to platinum therapy within 6 months.

I've had 1-5 treatments for cancer that didn't respond well to platinum, including one with bevacizumab.

Exclusion Criteria

My ovarian cancer is of the mucinous or carcinosarcoma type.

My ovarian tumor is non-epithelial or has low malignant potential.

I have been treated with anti-PD1/PD-L1 therapy before.

Treatment Details

Interventions

• Nemvaleukin (Cytokine)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview The study compares nemvaleukin alfa combined with pembrolizumab against a choice chemotherapy in patients who've had limited success with platinum-based treatments. It's an open-label Phase 3 trial where participants are randomly assigned to the treatment groups.

Participant Groups

Group I: Pembrolizumab (enrollment completed) Experimental Treatment 1 Intervention

Group II: Nemvaleukin and Pembrolizumab Combination Experimental Treatment 1 Intervention

Group III: Nemvaleukin (enrollment completed) Experimental Treatment 1 Intervention

Group IV: Investigator's Choice Active Control 4 Interventions

Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials

118

Recruited

27,200+

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

Trials

6

Recruited

1,100+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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