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Alkylating agents
Chemotherapy + Retifanlimab for Cancer
Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC
ECOG performance status 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
Study Summary
This trial will test a new chemotherapy drug for people with inoperable cancer that has spread locally or to other parts of the body.
Who is the study for?
This trial is for adults with inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC) who haven't had systemic chemotherapy. Participants must be able to perform daily activities with little assistance, have measurable disease, provide tissue and blood samples, and if HIV-positive, meet certain health criteria. Pregnant or breastfeeding individuals can't join, nor those with recent radiotherapy or certain infections.Check my eligibility
What is being tested?
The study tests the effectiveness of carboplatin-paclitaxel combined with either retifanlimab (a new drug) or a placebo in treating SCAC. It's a Phase 3 trial where participants are randomly assigned to one of the two groups without knowing which one they're in (double-blind).See study design
What are the potential side effects?
Possible side effects include allergic reactions to drugs used, nerve damage symptoms like numbness or tingling (neuropathy), immune-related issues such as inflammation of organs due to retifanlimab, and typical chemotherapy side effects like fatigue and digestive problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed and cannot be removed by surgery.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
AUC0-t of retifanlimab when administered with chemotherapy
Cmax of retifanlimab when administered with chemotherapy
Cmin of retifanlimab when administered with chemotherapy
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B : carboplatin+paclitaxel+retifanlimabExperimental Treatment3 Interventions
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
Group II: Group A : carboplatin+paclitaxel+placeboPlacebo Group2 Interventions
Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
retifanlimab
2018
Completed Phase 1
~30
carboplatin
2010
Completed Phase 3
~4790
paclitaxel
1996
Completed Phase 3
~4310
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
367 Previous Clinical Trials
55,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be willing to prevent pregnancy or having children during the study.I am HIV-positive with stable health, meeting all required health criteria.My cancer is confirmed and cannot be removed by surgery.I have not had another type of cancer in the past 3 years.I have had an organ or stem cell transplant.I do not have serious lung, heart, stomach, or autoimmune diseases.My cancer can be measured by scans and has grown in previously treated areas.I do not have any active infections and haven't used IV antibiotics in the last 7 days.I can provide recent tissue and blood samples for testing.You have severe allergies to platinum, paclitaxel, or certain medications that cannot be managed with standard treatments like antihistamines or corticosteroids.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had systemic therapy except as part of radiotherapy or completed over 6 months ago.I am 18 years old or older.I have active brain metastases or cancer in the lining of my brain.I had radiotherapy over 28 days ago, or palliative radiation within the last 14 days, with side effects mostly gone.I have previously received PD-(L)1 therapy.I have not received a live vaccine in the last 28 days.I am not taking any medications that are not allowed in this study.I have moderate to severe nerve damage in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Group B : carboplatin+paclitaxel+retifanlimab
- Group 2: Group A : carboplatin+paclitaxel+placebo
Awards:
This trial has 1 awards, including:- 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.
Are there known risks associated with paclitaxel treatments?
"Paclitaxel has been determined to be a safe medication, as it has received a score of 3. This is based on the fact that it is a Phase 3 trial, which means that there is data to support its efficacy as well as its safety."
Answered by AI
Are people with the desired condition able to enroll in this trial right now?
"That's right, the clinical trial is still open and recruiting patients. According to the information on clinicaltrials.gov, the trial was posted on 1/12/2021 and was last edited on 10/21/2022. They are looking for 300 participants at 18 different sites."
Answered by AI
When will this clinical trial end and how many patients will be seen total?
"Currently, there are 18 sites around the country enrolling patients for this trial. If you enroll, you will be asked to select the site nearest to you to minimize travel. The locations include Rochester, Dallas, Duarte, and 15 others."
Answered by AI
What other cancer treatments involve paclitaxel?
"As of now, there are 1253 ongoing clinical trials studying paclitaxel. Out of those, 344 are in the third and final stage. Even though the majority of these trials are based in Shanghai, China, there are 67120 locations around the world researching paclitaxel."
Answered by AI
What is the patient cohort size for this clinical trial?
"That is correct. The clinical trial was first posted on 1/12/2021 and was last updated on 10/21/2022. The study is recruiting for 300 patients at 18 sites."
Answered by AI
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