Health TrialsbyHealthPanel

Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

ConditionsKidney Transplant RecipientCutaneous Squamous Cell Carcinoma (CSCC)Advanced Cutaneous Squamous Cell CarcinomaKidney Transplant
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Anatomically unresectable disease to include carotid artery encasement; invasion into the skull base, cavernous sinus, sagittal sinus; pre-vertebral fascia/vertebral body/vertebral artery; disseminated distant metastatic disease

Functionally unresectable disease resulting in the loss of sight, oral competency/speech/swallowing, or limb

Biologically unresectable disease to include satellitosis, in-transit/dermal metastasis, or disease which has failed 2 or more prior surgeries (by an experienced CSCC surgeon) or failed curative intent radiation therapy

Measurable disease per RECIST 1.1.

Disqualifiers

Received chemotherapy or radiotherapy within 2 weeks prior to C1D1. Note: prior cetuximab exposure is permitted, but it must have been discontinued at least 2 weeks prior to the start of cemiplimab.

Received prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CLTA-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 or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial

Currently receiving any other investigational agents.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cemiplimab

    Drug

    Cemiplimab is administered intravenously (IV) at a dose of 350mg over 30 minutes on Day 1 of each 21-day cycle.

  • Prednisone

    Drug

    Prednisone is administered orally and taken about the same time each day. Prednisone will be pulsed for Cycles 1-6 and continued to be pulsed or dose reduced for Cycles 7+. For Cycles 1-6: 40 mg dose will be administered the day before each cycle (Day -1 or Day 21) and Days 1-3, 20mg dose Days 4-6, and 10mg dose Days 7-20. For Cycles 7+: Dose will be administered pulsed as Cycles 1-6 or 10mg daily

  • Sirolimus

    Drug

    Sirolimus will be taken orally once daily at dose prescribed to achieve a goal trough level of 4-6 ng/mL. It should be taken around the same time daily. Sirolimus will be administered daily throughout each cycle.

  • Cetuximab (EGFR inhibitor)

    Drug

    Cetuximab may be administered according to standard of care (SOC).

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Standard immunosuppression + Cemiplimab + Cetuximab (optional)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

ORR is defined as the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR will be assessed according to RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame
From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)

Secondary outcomes

1

Incidence of adverse events as assessed by CTCAE v6.0

Time frame
Start of lead-in treatment through 90 days after discontinuation of cemiplimab (total estimated time 27 months and 2 weeks)
2

Discontinuation of treatment due to treatment-related adverse events (AEs)

Defined as the proportion of patients who permanently discontinue any study treatment due to a treatment-related AE. AEs will be assessed by CTCAE v6.0.

Time frame
Start of lead-in treatment through completion of treatment (total estimated time 24 months and 2 weeks)
3

Kidney allograft rejection rate

Kidney allograft rejection rate is defined as the proportion of kidney transplant recipients who experience an episode of acute or chronic kidney rejection after receiving the study treatment.

Time frame
From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)
4

Allograft loss rate

Allograft loss rate is defined as the proportion of kidney transplant recipients whose transplanted kidney ceases to function after receiving the study treatment, assessed throughout the study.

Time frame
Start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: