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PD-1 Inhibitor
PD-1 Inhibitor vs. PD-1 + TIM-3 Inhibitors for Melanoma
Phase 2
Recruiting
Led By Diwakar Davar, MD
Research Sponsored by Diwakar Davar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of cutaneous or unknown primary melanoma (excluding uveal/choroidal and mucosal melanoma; although acral melanoma is included) belonging to specific AJCC 8th edition TNM stages
N1b, or N1c, or N2b, or N2c, or N3b, or N3c AND/OR M1a
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 months
Awards & highlights
Study Summary
This trial is testing two different types of drugs to treat melanoma. One is an anti-PI-1 inhibitor, and the other is a combination of anti-PD-1 and anti-TIM-3.
Who is the study for?
Adults with operable melanoma, including primary melanoma with regional metastasis or recurrence, are eligible for this trial. They must have adequate organ function and provide a recent tumor biopsy. Pregnant women and individuals on systemic immunosuppression or with certain autoimmune diseases, other active cancers, or severe psychiatric issues cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of Dostarlimab (TSR-042) alone versus its combination with Cobolimab (TSR-022) in treating melanoma before surgery. Participants will be randomly assigned to receive one of these two treatment options.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect various organs, infusion-related symptoms like fever or chills, fatigue, possible hormonal gland problems leading to hormone deficiencies, skin reactions at injection sites and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is not related to the eye or mucous membranes but confirmed by a lab test.
Select...
My cancer has spread to nearby lymph nodes or distant parts of my body.
Select...
I am 18 years old or older.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Pathologic Response (MPR)
Secondary outcome measures
Frequency of Cancellations of Surgery
Frequency of Delays in Surgery
Number of Participants Experiencing Adverse Events Attributed to Treatment
+2 moreOther outcome measures
Percentage of Circulating immune cells
Percentage of Intratumoral immune cells
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dostarlimab (TSR-042) and TSR-022 (combination)Experimental Treatment1 Intervention
Pre-Operative Phase:
Dostarlimab (TSR-042) 500mg and TSR-022 300mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1 and then again on Cycle 2 Day 1.
Post-Operative Phase:
Dostarlimab (TSR-042) will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks. TSR-022 will not be administered.
Group II: Dostarlimab (TSR-042) (singly)Experimental Treatment1 Intervention
Pre-Operative Phase:
Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.
Post-Operative Phase:
Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 doses every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks.
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Who is running the clinical trial?
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,500 Total Patients Enrolled
2 Trials studying Melanoma
45 Patients Enrolled for Melanoma
Diwakar DavarLead Sponsor
10 Previous Clinical Trials
355 Total Patients Enrolled
8 Trials studying Melanoma
299 Patients Enrolled for Melanoma
Diwakar Davar, MD5.01 ReviewsPrincipal Investigator - UPMC Hillman Cancer Center
University of Pittsburgh
7 Previous Clinical Trials
207 Total Patients Enrolled
6 Trials studying Melanoma
181 Patients Enrolled for Melanoma
5Patient Review
Dr. Davar is always so patient with me and takes the time to ensure I understand everything. After my melanoma diagnosis, it's been difficult to process information, but he is very thorough and caring.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is getting worse or needs treatment.My invasive cancer was diagnosed and treated within the last 2 years.I agree to use birth control during the study.You have a history of hepatitis B or C, or a positive test for these viruses.My melanoma is not related to the eye or mucous membranes but confirmed by a lab test.I had a severe autoimmune reaction to previous immunotherapy.I do not have uveal or mucosal melanoma.My cancer has spread to nearby lymph nodes or distant parts of my body.I have had a severe side effect from previous immunotherapy.My cancer has spread to my brain or spinal cord.You have a medical condition or abnormal test results that the doctor thinks is important.I can provide a recent biopsy sample of my tumor.I have previously been treated with specific inhibitors or immunotherapies.My melanoma has spread to nearby lymph nodes or skin but can be surgically removed.I am taking medication to suppress my immune system for an autoimmune disease.I have a lung condition not caused by an infection.My melanoma has spread to nearby lymph nodes or skin but is still considered operable.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.I have been diagnosed with HIV.I have not received a live vaccine in the last 30 days.I am currently on medication for an infection.I can provide a recent sample of my tumor for testing.I am a woman who cannot become pregnant due to age or medical reasons.Women who could become pregnant must have a negative pregnancy test.I am 18 years old or older.You have a disease that can be measured using a specific set of guidelines called RECIST 1.1.I am fully active or can carry out light work.Women who could become pregnant must have a negative pregnancy test.My recent tests show my organs are working well.You have a disease that can be measured using a specific method called RECIST 1.1.
Research Study Groups:
This trial has the following groups:- Group 1: Dostarlimab (TSR-042) and TSR-022 (combination)
- Group 2: Dostarlimab (TSR-042) (singly)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any openings currently available to join this research effort?
"According to the data on clinicaltrials.gov, this clinical trial is actively seeking out participants. It was launched in April 2020 and its information has been updated as recently as February 2022."
Answered by AI
How many people can participate in this clinical research endeavor?
"Tesaro, Inc. is responsible for the trial's operations and requires 56 participants that meet all inclusion criteria to proceed with their research. The Georgetown University Medical Center in Washington DC and Massachusetts General Hospital in Boston are two of the many sites involved in this clinical study."
Answered by AI
Has the FDA authorized Dostarlimab (TSR-042) and TSR-022 (in tandem)?
"With Phase 2 trials having provided limited evidence regarding the safety of Dostarlimab (TSR-042) and TSR-022, our team at Power rates it a 2 on their scale. Unfortunately, there is no data supporting efficacy yet."
Answered by AI
Can you provide an overview of any preceding research that has explored the efficacy of Dostarlimab (TSR-042) and TSR-022 (combination)?
"The original research on Dostarlimab (TSR-042) and TSR-022 was conducted at City of Hope in 2010. Subsequently, 1 clinical study has been completed, with an additional 40 ongoing projects primarily situated in the Washington DC area."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
New York
Texas
How old are they?
65+
18 - 65
What site did they apply to?
UPMC Hillman Cancer Center
Massachusetts General Hospital
Georgetown University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Massachusetts General Hospital: < 48 hours
- Georgetown University Medical Center: < 48 hours
Average response time
- < 2 Days
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