Clinical Trials /

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

NCT04050436

Description:

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
  • Official Title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: RPL-002-18
  • NCT ID: NCT04050436

Conditions

  • Cutaneous Squamous Cell Carcinoma
  • Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
CemiplimabLibtayoCemiplimab
RP1Genetically modified herpes simplex type 1 virusCemiplimab in combination with RP1

Purpose

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.

Trial Arms

NameTypeDescriptionInterventions
Cemiplimab in combination with RP1ExperimentalCemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
  • Cemiplimab
  • RP1
CemiplimabActive ComparatorCemiplimab administered intravenously as a single therapy every 3 weeks
  • Cemiplimab

Eligibility Criteria

        Key Inclusion Criteria:

          -  Histologically confirmed locally advanced or metastatic cutaneous squamous cell
             carcinoma

          -  Patients for whom surgical or radiological treatment of lesions is contraindicated

          -  At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm
             in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1

          -  Anticipated life expectancy >12 weeks

          -  All patients must consent to provide archived or newly obtained tumor material for
             central pathology review for confirmation of diagnosis of CSCC.

        Key Exclusion Criteria:

          -  Prior treatment with an oncolytic therapy

          -  Patients with active significant herpetic infections or prior complications of HSV-1
             infection (e.g. herpetic keratitis or encephalitis)

          -  Patients who require intermittent or chronic use of systemic (oral or intravenous)
             anti-virals with known anti-herpetic activity (e.g. acyclovir)

          -  Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
             required treatment with systemic immunosuppressive treatments

          -  Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.

          -  Prior treatment with other immune modulating agents other than as adjuvant or
             neoadjuvant therapy.

          -  Untreated brain metastasis(es) that may be considered active.

          -  Known infection including active infection with hepatitis B virus (HBV), hepatitis C
             virus (HCV) or human immunodeficiency virus (HIV).

          -  History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis
             requiring treatment with systemic steroids.

        Note: Other protocol defined Inclusion/Exclusion criteria apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review
Time Frame:36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:ORR for patients with metastatic or locally advanced disease
Time Frame:36 months
Safety Issue:
Description:
Measure:ORR for patients who have and have not previously received systemic CSCC-directed therapy
Time Frame:36 months
Safety Issue:
Description:
Measure:ORR by investigator assessment
Time Frame:approximately 36 months
Safety Issue:
Description:
Measure:Rate of individual tumor response in injected versus non-injected lesions
Time Frame:36 months
Safety Issue:
Description:
Measure:Duration of Response (DOR) per central and investigator review
Time Frame:36 months
Safety Issue:
Description:
Measure:Progression-free Survival (PFS) per central and investigator review
Time Frame:36 months
Safety Issue:
Description:
Measure:Complete response (CR) rate per central and investigator review
Time Frame:36 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:approximately 36 months
Safety Issue:
Description:
Measure:Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs)
Time Frame:36 months
Safety Issue:
Description:Overall adverse event rates and adverse event rates per observation period will be compared for the two treatment groups using a two-sided Fisher Exact test. Results will be analyzed by SOC and for preferred terms with >10% overall incidence.
Measure:Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame:36 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Replimune Inc.

Trial Keywords

  • Oncolytic Virus
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Cemiplimab
  • Metastatic Cutaneous Squamous Cell Carcinoma
  • Oncolytic Immuno-gene therapy

Last Updated

April 15, 2020