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PD-1 Inhibitor
Cemiplimab for Squamous Cell Carcinoma (CONTRAC Trial)
Phase 1 & 2
Waitlist Available
Led By Glenn J Hanna, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
Patients must have histologically confirmed, advanced or metastatic cutaneous squamous cell carcinoma (cSCC) with 1 or more measurable lesions (greater than or equal to 1 cm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
CONTRAC Trial Summary
This trial is studying Cemiplimab to see how well it works in treating patients with advanced cutaneous squamous cell carcinoma who have had a hematopoietic stem cell transplant or kidney transplant.
Who is the study for?
Adults with advanced skin cancer who've had a stem cell or kidney transplant can join. They need to be in decent health, have good organ function, and no severe immune conditions. Women must test negative for pregnancy and use contraception; men also need to use effective birth control.Check my eligibility
What is being tested?
The trial is testing Cemiplimab's effectiveness on advanced cutaneous squamous cell carcinoma in patients post-transplant. It includes drugs like Everolimus or Sirolimus and Prednisone as part of the treatment regimen.See study design
What are the potential side effects?
Possible side effects include immune system reactions, increased risk of infections, potential liver issues indicated by changes in certain blood tests, fatigue, and possibly other drug-specific reactions.
CONTRAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do active work.
Select...
I have advanced skin cancer with a tumor larger than 1 cm.
Select...
I am 18 years old or older.
CONTRAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Dose Limiting Toxicity
Secondary outcome measures
Overall Response Rate
Overall Survival Rate
Progression Free Survival Rate
+2 moreSide effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
CONTRAC Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 Cemiplimab + Everolimus/Sirolimus + PrednisoneExperimental Treatment4 Interventions
Participants who received a kidney transplant will receive
Cemiplimab via IV, flat predetermined dosage every 21 days
Everolimus or Sirolimus-least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab
Prednisone 40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapering doses while receiving Cemiplimab
Group II: Cohort 1 CemiplimabExperimental Treatment1 Intervention
Participants who received allogeneic hematopoietic stem cell transplant
-- Cemiplimab: via IV, flat predetermined dosage every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Cemiplimab
FDA approved
Everolimus
FDA approved
Sirolimus
FDA approved
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
619 Previous Clinical Trials
380,243 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,974 Total Patients Enrolled
Glenn J Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
115 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses.I can care for myself but may not be able to do active work.I have advanced skin cancer with a tumor larger than 1 cm.I have previously been treated with specific immunotherapies.I am taking medication that strongly affects liver enzyme activity.I have been treated with the drug idelalisib before.I am 18 years old or older.I have had chemotherapy or radiotherapy recently.I meet the requirements for either Cohort 1 or Cohort 2.I have a history of lung inflammation not caused by infection.I have brain metastases that have not been treated.My organs and bone marrow are functioning well.I haven't taken high doses of corticosteroids in the last 4 weeks.I agree to follow the specified birth control methods.I am a kidney transplant recipient experiencing active rejection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 Cemiplimab
- Group 2: Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- 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 enrollment applications for this clinical trial still accepted?
"Affirmative. Clinicaltrials.gov data confirms that this research project, which went live on July 15th 2020, is currently recruiting participants. Specifically, 12 individuals must be sourced from a single centre."
Answered by AI
What other investigational studies have examined the efficacy of Cemiplimab?
"Presently, the drug Cemiplimab is being investigated in 590 independent clinical trials. Of those studies, 124 are Phase 3 investigations taking place at Duarte, California and other 23,043 locations globally."
Answered by AI
How many participants have signed up thus far to partake in this research?
"Affirmative. According to the clinicaltrials.gov website, this clinical trial was initially posted on July 15th 2020 and is still actively recruiting participants. There are currently 12 patients needed from a single location."
Answered by AI
In what context is Cemiplimab typically prescribed?
"Cemiplimab is frequently used to combat thyroiditis, as well as other ailments such as lung issues, advanced carcinoid tumor and ulcerative colitis."
Answered by AI
Has Cemiplimab been granted regulatory clearance by the FDA?
"Due to a limited data set that supports its efficacy and safety, Cemiplimab was rated as 1 out of 3 on the Power team's scale."
Answered by AI
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