A Phase 2 Study of Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC-2)

Summary

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

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Cemiplimab

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

• Drug
  Prednisone

  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

• Drug
  Sirolimus

  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.

• Drug
  Cetuximab (EGFR inhibitor)

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

Location