Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors

Conditions

• Advanced or Metastatic Cutaneous Squamous Cell Carcinoma
• Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
• Advanced or Metastatic Melanoma
• Advanced or Metastatic Merkel Cell Carcinoma
• Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cavrotolimod — DRUG
  Intratumorally dosed cavrotolimod.
• Pembrolizumab — BIOLOGICAL
  Pembrolizumab dosing as per the US prescribing information.
• Cemiplimab — BIOLOGICAL
  Cemiplimab dosing as per the US prescribing information.
• Cavrotolimod — DRUG
  Subcutaneously dosed cavrotolimod

Study Details

This is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.

Key Dates

Start date

Dec 13, 2018

Status verified

Mar 2022

Primary completion

Mar 30, 2022

Completion

Mar 30, 2022

Study Design

Enrollment

57 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Phase 1b
  Determine the recommended Phase 2 dose of cavrotolimod in combination with pembrolizumab.
• Experimental: Dose Expansion Phase 2; Merkel cell carcinoma
  Determine the safety and preliminary efficacy of cavrotolimod and pembrolizumab in patients with advanced Merkel cell carcinoma that have progressed on an anti-PD-1 / anti-PD-L1 therapy.
• Experimental: Dose Expansion Phase 2, cutaneous squamous cell carcinoma
  Determine the safety and preliminary efficacy of cavrotolimod and cemiplimab in patients with advanced cutaneous squamous cell carcinoma that have progressed on an anti-PD-1.
• Experimental: Exploratory Phase 2, Merkel cell carinoma
  Determine the safety and preliminary efficacy of cavrotolimod and pembrolizumab in patients with advanced Merkel cell carcinoma that have progressed on anti-PD-1 / anti-PD-L1 therapy.
• Experimental: Exploratory Phase 2, Subcutaneous Dosing Cohort
  Determine the safety and preliminary efficacy of cavrotolimod and pembrolizumab in patients with no cutaneous, subcutaneous, or accessible nodal tumor lesions amenable that have progressed on anti-PD-1 / anti-PD-L1 therapy.
• Experimental: Exploratory Phase 2, Melanoma
  Determine the safety and preliminary efficacy of cavrotolimod and pembrolizumab in patients with locally Advanced or Metastatic Melanoma that have progressed on anti-PD-1 / anti-PD-L1 therapy.
• Experimental: Exploratory Phase 2, Liver Lesion
  Determine the safety and preliminary efficacy of cavrotolimod and pembrolizumab in patients with metastatic solid tumors with liver metastases that have progressed on anti-PD-1 / anti-PD-L1 therapy.

Primary Outcome Measure

Adverse events of cavrotolimod alone and in combination with pembrolizumab or cemiplimab [ Time Frame: Study day 36 ]

Locations (26)

Find similar trials in Tucson, AZ

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