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GSK6097608 + Dostarlimab for Advanced Cancers
Study Summary
This trial will test the safety and effectiveness of a new drug, GSK6097608, given alone or with another new drug, dostarlimab, to people with advanced solid tumors. The trial will also test dostarlimab given alone or with GSK6097608 and with another new drug, GSK4428859A (EOS884448), to people with advanced solid tumors in Japan and China.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- You have a history of drug or alcohol abuse.I have had a bone marrow or organ transplant.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I had severe side effects from cancer treatment that stopped my therapy or have ongoing side effects.I do not have uncontrolled brain metastases or cancer in the lining of my brain.I haven't had allergen desensitization therapy in the last 4 weeks.I haven't received blood products or colony-stimulating factors in the last 14 days.I have not received a live vaccine in the last 30 days.You have had an allergic reaction to any of the study treatments or their ingredients.I agree to use effective birth control if I can have children.I have had another cancer that got worse or needed treatment in the last 2 years.I have an autoimmune disease treated with strong medication in the last 2 years.I am on medication that weakens my immune system.I have had fluid build-up in my abdomen or chest that was not controlled in the last 6 months.My cancer is advanced, has come back, or has spread to other parts.My organ functions are within normal ranges according to recent tests.I have a history of serious lung conditions that needed steroids.I am at least 18 years old, or 20 if participating in certain Japan arms.I have not had major surgery within the last 4 weeks.I have a history of serious heart problems.I do not have an active infection needing treatment, HIV, or hepatitis B/C.My liver is not stable or I have cirrhosis, as assessed by my doctor.My cancer has worsened after standard treatment or standard treatment was not suitable for me.I can provide a fresh sample of my tumor for the study.You are expected to live for at least 3 months (12 weeks).
- Group 1: Participants receiving dostarlimab plus belrestotug (Arm E)
- Group 2: Participants receiving dostarlimab plus cobolimab (Arm G)
- Group 3: Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)
- Group 4: Participants receiving dostarlimab monotherapy (Arm D)
- Group 5: Participants receiving GSK6097608 monotherapy (Arm A)
- Group 6: Participants receiving GSK6097608 plus dostarlimab (Arm B)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the clinical history of GSK6097608?
"GSK6097608 was first researched at City of Hope a decade ago. So far, 1 study has been completed while 41 studies are ongoing. Many of these active trials taking place in Boston, Massachusetts."
Are there different test locations for this North American clinical trial?
"To make participation more convenient for patients, this study is being conducted at 7 locations. These sites are situated in Boston, Ottawa, Toronto, and other cities."
Could you please detail GSK6097608's safety profile?
"GSK6097608 is still in early testing, so there is limited data supporting its safety and efficacy. We've given it a score of 1."
How many people are testing this medication?
"That is accurate. The information available on clinicaltrials.gov indicates that this trial is actively seeking participants. This trial was posted on June 25th, 2020 and was last updated on August 26th, 2020. The goal is to recruit 178 patients from 7 different sites."
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