Trial Outcomes & Findings for Cemiplimab in AlloSCT/SOT Recipients With CSCC (NCT NCT04339062)

Last Updated: 2025-04-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

First dose of study treatment up to 100 days

Results posted on

2025-04-23

Participant Flow

This is a phase I, single-arm, single-center, nonrandomized trial that enrolled patients at Dana-Farber Cancer Institute. The trial design originally included two parallel cohorts, one for allogeneic stem-cell transplant recipients and the other for patients with prior kidney transplantation. The stem-cell transplant cohort (Cohort 1) closed for slow accrual in November 2021 with no enrolled patients.

Participant milestones

Participant milestones
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone Participants with a prior 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Overall Study STARTED	0	12
Overall Study COMPLETED	0	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone Participants with a prior 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Overall Study Death	0	1

Baseline Characteristics

Cemiplimab in AlloSCT/SOT Recipients With CSCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=12 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab	Total n=12 Participants Total of all reporting groups
Age, Continuous	—	62.2 Years STANDARD_DEVIATION 12.6 • n=107 Participants	62.2 Years STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male Female	—	2 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	—	10 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	11 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	—	11 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) More than one race	—	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=107 Participants	0 Participants n=206 Participants
Years between initial diagnosis and enrollment	—	2.5 Years n=107 Participants	2.5 Years n=206 Participants
Weeks between initial diagnosis and local or regional recurrence	—	70.4 Weeks n=107 Participants	70.4 Weeks n=206 Participants
Site of recurrent disease Regional	—	8 Participants n=107 Participants	8 Participants n=206 Participants
Site of recurrent disease Local	—	4 Participants n=107 Participants	4 Participants n=206 Participants

PRIMARY outcome

Timeframe: First dose of study treatment up to 100 days

Population: No patients enrolled into 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.

Outcome measures

Outcome measures
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=12 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1).	—	0 Percentage of participants Interval 0.0 to 22.0

SECONDARY outcome

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

Population: No patients enrolled into Cohort 1.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=12 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Progression-Free Survival	—	22.5 Months Interval 1.2 to 29.8

SECONDARY outcome

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

Population: No patients enrolled into Cohort 1.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=12 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Overall Survival	—	22.5 Months Interval 2.9 to 29.8

SECONDARY outcome

Timeframe: Up to 1 year

Population: Eleven of 12 patients had scans to assess RECIST response.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=11 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Overall Response Rate	—	45.5 Percentage of participants Interval 20.0 to 73.0

SECONDARY outcome

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

Population: Patients with best response of CR or PR per RECIST.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=5 Participants 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Duration of Response	—	11.4 Months Interval 4.9 to 29.7

Adverse Events

Cohort 1 Cemiplimab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone

Serious events: 9 serious events

Other events: 12 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Glenn Hanna

Dana-Farber Cancer Institute

Phone: 617-632-3090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 Cemiplimab Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days.	Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone n=12 participants at risk 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 Cemiplimab: Cemiplimab: via IV, flat predetermined dosage every 21 days. Everolimus: Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab Sirolimus: Sirolimus at 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 tapered dosing while receiving Cemiplimab
Blood and lymphatic system disorders Anemia	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Cardiac disorders Atrial fibrillation	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Cardiac disorders Cardiac stent placement	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
General disorders Fever	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Infections and infestations Lung infection	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	16.7% 2/12 • Number of events 2 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Infections and infestations Skin infection	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Infections and infestations Soft tissue infection	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Infections and infestations Upper respiratory infection	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	33.3% 4/12 • Number of events 4 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Investigations Creatinine increase	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Metabolism and nutrition disorders Acidosis	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Metabolism and nutrition disorders Hyperkalemia	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Metabolism and nutrition disorders Hypoalbuminemia	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Respiratory, thoracic and mediastinal disorders Hypoxia	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Vascular disorders Hypotension	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	8.3% 1/12 • Number of events 1 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.
Vascular disorders Thromboembolic event	— 0/0 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.	16.7% 2/12 • Number of events 2 • All adverse events reported through study completion (up to 36 months). No patients enrolled into Cohort 1.