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Cytokine

Nemvaleukin + Pembrolizumab for Ovarian Cancer (ARTISTRY-7 Trial)

Phase 3
Waitlist Available
Research Sponsored by Alkermes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy
Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
Must not have
Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new cancer treatment against chemotherapy to see which is more effective in patients with ovarian cancer that has not responded to platinum-based drugs.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab (like skin issues, colitis), cytokine release syndrome from nemvaleukin alfa (flu-like symptoms), and typical chemotherapy effects such as nausea, fatigue, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer got worse or didn't respond to platinum therapy within 6 months.
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My cancer got worse or didn't respond to platinum therapy within 6 months.
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I've had 1-5 treatments for cancer that didn't respond well to platinum, including one with bevacizumab.
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I have a tumor that can be measured by medical imaging.
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I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My ovarian cancer is of the mucinous or carcinosarcoma type.
Select...
My ovarian tumor is non-epithelial or has low malignant potential.
Select...
I have been treated with anti-PD1/PD-L1 therapy before.
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My cancer got worse during or right after my first platinum-based treatment.
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I have previously received treatments involving IL-2, IL-15, or IL-12.
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I needed fluid drained from my body (like from the abdomen or chest) and it was more than 500 mL in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab (enrollment completed)Experimental Treatment1 Intervention
Group II: Nemvaleukin and Pembrolizumab CombinationExperimental Treatment1 Intervention
Group III: Nemvaleukin (enrollment completed)Experimental Treatment1 Intervention
Group IV: Investigator's ChoiceActive Control4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
115 Previous Clinical Trials
26,524 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,527 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,524 Patients Enrolled for Ovarian Cancer
Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
631 Total Patients Enrolled

Media Library

Nemvaleukin (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05092360 — Phase 3
Ovarian Cancer Research Study Groups: Nemvaleukin (enrollment completed), Pembrolizumab (enrollment completed), Nemvaleukin and Pembrolizumab Combination, Investigator's Choice
Ovarian Cancer Clinical Trial 2023: Nemvaleukin Highlights & Side Effects. Trial Name: NCT05092360 — Phase 3
Nemvaleukin (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092360 — Phase 3
~170 spots leftby May 2026
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