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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

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

No Placebo-Only Group

Pivotal Trial

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:

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My ovarian cancer is of the mucinous or carcinosarcoma type.

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~3150

0 / 11Eligibility criteria met