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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)

Must not have

Uncontrolled intercurrent illness including specified conditions

Prior treatment with specified immunotherapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 30 Other Conditions

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may not be able to do active work.

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I have advanced skin cancer with a tumor larger than 1 cm.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses.

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I have previously been treated with specific immunotherapies.

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I am taking medication that strongly affects liver enzyme activity.

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I have been treated with the drug idelalisib before.

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I have a history of lung inflammation not caused by infection.

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I have brain metastases that have not been treated.

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I haven't taken high doses of corticosteroids in the last 4 weeks.

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I am a kidney transplant recipient experiencing active rejection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1).

Secondary study objectives

Duration of Response

Overall Response Rate

Overall Survival

+1 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Subcutaneous abscess

13%

Diarrhoea

13%

Hyperthyroidism

13%

Nausea

13%

Constipation

13%

Infusion related reaction

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

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.

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

Cemiplimab

FDA approved

Prednisone

FDA approved

Everolimus

FDA approved