AzTrials
AzTrials

Cutaneous Squamous Cell CarcinomaPhase 1/2CONTRACNCT04339062

Cemiplimab in AlloSCT/SOT Recipients With CSCC

A Phase 1/2 study testing Cemiplimab, Everolimus and Sirolimus in people with Cutaneous Squamous Cell Carcinoma and Advanced Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab, Everolimus and Sirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
3 Nov 2020to 1 Mar 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • A history of either (Cohort 1) allogeneic hematopoietic stem cell transplant (alloHSCT) and ≥ 2 years or 730 days from day 0 of their HSCT with adequate bone marrow function (see Section 3.1.6) and off of all systemic immunosuppression (topical agents permitted) for at least 3 months prior to enrollment; sequelae of chronic graft versus host disease (GVHD) is permitted (i.e. chronic dry eyes, sclerodermatous skin changes, etc.) if the patient is not on systemic immunosuppression, or (Cohort 2) a renal transplant with a functioning allograft (at least 6 months from allograft transplant) as determined by estimated glomerular filtration (GFR) rate (CKD-EPI equation [40], Appendix A) ≥30 mL/min, baseline proteinuria lower than 0.5 g/day (spot urine protein-creatinine ratio), and off antiproliferative immunosuppressive medications.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix B).
  • Participants must have adequate organ and marrow function as defined below:
  • leukocytes ≥ 2,200/mcL
Show all 19Show fewer
  • absolute neutrophil count ≥ 1,000/mcL
  • platelets ≥ 90,000/mcL
  • total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be < 3 mg/dL)
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
  • creatinine ≤ 1.5 × institutional upper limit of normal OR
  • estimated GFR ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (CKD-EPI equation).
  • urine protein/creatinine ratio < 0.5 (equal to less than 500 mg of proteinuria per day)
  • Ability to understand and the willingness to sign a written informed consent document.
  • A prior history of acute GVHD that has resolved, or sequelae of chronic GVHD following allo-HSCT is permitted. Active acute GVHD patients are excluded.
  • Women of childbearing potential (WOCBP) must agree to use at least 1 highly effective form of contraception (refer to Appendix C for examples). WOCBP should plan to use an adequate method to avoid pregnancy for up to 7 months (30 days plus the time required for cemiplimab to undergo five half-lives) after the last dose of investigational drug.
  • "Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche, who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), who is not postmenopausal, who is sexually active with a male partner. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
  • Women of childbearing potential, as defined above, must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of cemiplimab.
  • Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential as defined above, and azoospermic men) do not require contraception. See Appendix C for further guidance on contraception

Who cannot join

  • Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have unresolved toxicities from prior anti-cancer therapy more than 4 weeks earlier, defined as not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 5.0), grade 0 or 1.
  • Participants who are receiving any other investigational agents.
  • For Cohort 1 allo-HSCT patients enrolling to the study, corticosteroid doses > 10 mg of prednisone daily or equivalent within 4 weeks of the first dose of PD-1 inhibitor are prohibited. For Cohort 2 renal transplant patients enrolling to the study, corticosteroid use is permitted if used as part of their immunosuppressive regimen for graft protection prior to enrollment.
  • Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded.
  • Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
  • Kidney transplant recipients with active acute rejection.
Show all 13Show fewer
  • Allergy to cemiplimab or any of its components.
  • Any prior exposure to the phosphoinositide 3-kinase inhibitor idelalisib.
  • Subject who has been treated with immunotherapy. This includes prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (including chimeric antigen receptor [CAR] T cell therapies). Prior topical or intralesional immunotherapies (e.g. imiquimod, talimogene laherparepvec) are allowed.
  • Subject with known and untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic. Patients at least 4 weeks out from metastatic central nervous system (CNS) treatment are permitted to enroll, if they are asymptomatic, radiographically stable per the investigator, and on stable doses of anti-epileptic drugs (AEDs) and oral corticosteroids (for Cohort 1 only, the patient must be on 10 mg of prednisone daily equivalent dosing or less, see 3.2.2) at the time of enrollment.
  • Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as [http://medicine.iupui.edu/clinpharm/ddis/table.aspx]. Medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Known non-infectious pneumonitis or any history of interstitial lung disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Safety and Efficacy of Cemiplimab (PD-1 Blockade) in Selected Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC)

In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant.

  • This research study involves the following drug(s):
  • Cemiplimab
  • Everolimus or Sirolimus
  • Prednisone
Read the detailed description
  • This an open-label, two cohort, phase I/II research study to evaluate the safety and effectiveness of Cemiplimab as a treatment for advanced cutaneous squamous cell carcinoma in participants who have received allogeneic hematopoietic stem cell or kidney transplants.
  • The research study procedures include screening for eligibility, study treatment, participant evaluations and safety follow-up visits. It is expected that about 12 people will take part in this research study.
  • Participants will be divided into two groups (cohorts) of allogeneic hematopoietic stem cell recipients or kidney transplants recipients.
  • Allogeneic hematopoietic stem cell recipients will only receive the study treatment drug of Cemiplimab.
  • Kidney transplant recipients will receive the study treatment drug of Cemiplimab along with the immunosuppressant drugs of Everolimus or Sirolimus and Prednisone to prevent kidney rejection.

The U.S. Food and Drug Administration (FDA) has approved Cemiplimab as a treatment option for patients with advanced cutaneous squamous cell cancer, but the FDA has not approved the use of Cemiplimab in participants who have received allogeneic hematopoietic stem cell transplants or kidney transplants in the past.

-- Cemiplimab is a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved this type of cancer.

Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.

Being tested
Cemiplimab, Everolimus, Sirolimus, Prednisone
Keywords
Cutaneous Squamous Cell Carcinoma, Advanced Cancer, Allogeneic hematopoietic stem cell transplant, Kidney transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called Libtayo

    Cemiplimab: via IV, flat predetermined dosage every 21 days.

  • EverolimusDrug

    Also called Afinitor, Zortress

    Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab

  • SirolimusDrug

    Also called Rapamune

    Sirolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab

  • PrednisoneDrug

    Also called Deltasone, Prednicot, predniSONE Intensol, Rayos

    40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapered dosing while receiving Cemiplimab

Study groups in NCT04339062
Study groupRoleWhat they receive
Cohort 1 CemiplimabExperimentalParticipants who received allogeneic hematopoietic stem cell transplant -- Cemiplimab: via IV, flat predetermined dosage every 21 days
Receives: Drug: Cemiplimab
Cohort 2 Cemiplimab + Everolimus/Sirolimus + PrednisoneExperimentalParticipants 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
Receives: Drug: Cemiplimab; Drug: Everolimus; Drug: Sirolimus; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The proportions of patients who have observed GVHD in Cohort 1 or renal transplant rejection in Cohort 2.

    Participants will be evaluable for from the time of their first treatment.

    Measured: First dose of study treatment up to 100 days

Secondary outcomes (4)

  1. Progression-Free Survival

    Time from registration to the earlier of progression or death due to any cause. The follow-up of patients who neither progress nor die is censored at the date of last follow-up.

    Measured: Duration of follow-up (up to 36 months)

  2. Overall Survival

    Time from registration to death due to any cause. Follow-up of patients who did not die will be censored at the date of last vital status.

    Measured: Duration of follow-up (up to 36 months)

  3. Overall Response Rate

    The proportion of patients with best response of complete (CR) or partial (PR) response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Measured: Up to 1 year

  4. Duration of Response

    Duration of response is estimated in the subset of patients with best response of complete or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions. Duration of response is the time interval between dates of CR or PR and disease progression. The follow-up of patients who did not progress is censored at the date of the last follow-up scan.

    Measured: Duration of follow-up (up to 36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2020
  2. Study start3 Nov 2020
  3. Primary completion12 Jun 2023
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339062
Sponsor's protocol ID
19-817
Acronym
CONTRAC
Status last verified
Apr 2025
First submitted
7 Apr 2020
Last updated
23 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Hanna GJ, Dharanesswaran H, Giobbie-Hurder A, Harran JJ, Liao Z, Pai L, Tchekmedyian V, Ruiz ES, Waldman AH, Schmults CD, Riella LV, Lizotte P, Paweletz CP, Chandraker AK, Murakami N, Silk AW. Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma. J Clin Oncol. 2024 Mar 20;42(9):1021-1030. doi: 10.1200/JCO.23.01498. Epub 2024 Jan 22.

    PubMed 38252908

  • Bonilla M, Gudsoorkar P, Wanchoo R, Herrmann SM, Jhaveri KD. Onconephrology 2022: An Update. Kidney360. 2023 Feb 1;4(2):258-271. doi: 10.34067/KID.0001582022. Epub 2022 Dec 9.

    PubMed 36821617

  • Paoluzzi L, Ow TJ. Safe Administration of Cemiplimab to a Kidney Transplant Patient with Locally Advanced Squamous Cell Carcinoma of the Scalp. Curr Oncol. 2021 Jan 19;28(1):574-580. doi: 10.3390/curroncol28010057.

    PubMed 33477979

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cemiplimab, Everolimus and Sirolimus in people with Cutaneous Squamous Cell Carcinoma and Advanced Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1). (time frame: First dose of study treatment up to 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04339062, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in