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Cytokine
Nemvaleukin + Pembrolizumab for Ovarian Cancer (ARTISTRY-7 Trial)
Phase 3
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ARTISTRY-7 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.Check my eligibility
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.See study design
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.
ARTISTRY-7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
ARTISTRY-7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG)
Disease Control Rate (DCR) as assessed by Investigator
Duration of Response (DOR) as assessed by Investigator
+4 moreARTISTRY-7 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
~2010
Find a Location
Who is running the clinical trial?
Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,440 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,698 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
627 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am a woman and I am 18 years old or older.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.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.I have a tumor that can be measured by medical imaging.I have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer.My cancer got worse during or right after my first platinum-based treatment.I have previously received treatments involving IL-2, IL-15, or IL-12.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.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab (enrollment completed)
- Group 2: Nemvaleukin (enrollment completed)
- Group 3: Nemvaleukin and Pembrolizumab Combination
- Group 4: Investigator's Choice
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the risk of serious side effects for patients taking Nemvaleukin and Pembrolizumab together?
"Nemvaleukin and Pembrolizumab Combination have both undergone Phase 3 clinical trials, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety. For this reason, our team at Power has estimated the safety of this combination to be a 3 on a scale from 1 to 3."
Answered by AI
For what purpose is the Nemvaleukin and Pembrolizumab Combination most often prescribed?
"While this medication is most commonly used to treat unresectable melanoma, it can also be effective for patients with microsatellite instability high, neuroblastoma (nb), and a high risk of recurrence."
Answered by AI
Are there many locations where this trial is taking place?
"There are a total of 18 different sites running this trial, so there may be a location near you. The sites are located in cities such as Fort Worth, Austin, New Brunswick, and others. If you decide to enroll in the trial, it would be best to choose the clinic closest to your home to reduce travel time and expenses."
Answered by AI
Are there any existing studies that have looked into the effects of combining Nemvaleukin with Pembrolizumab?
"2364 studies on the Nemvaleukin and Pembrolizumab Combination are ongoing, with 509 of them in Phase 3. Though a significant portion of these trials are located in Shanghai, China, there are 98437 different research sites around the world conducting these trials."
Answered by AI
Is this a pioneering clinical trial?
"Alfacell's 1997 clinical trial for Nemvaleukin and Pembrolizumab Combination, which involved 300 participants, completed Phase 3 approval in 1997. Since then, 2720 similar studies have been completed across 88 countries and 4292 cities. As of now, there are 2364 active studies."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Alkermes Investigator Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Other Trials to Consider
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