Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are:

  • How many participants' cancers respond to vidutolimod together with cemiplimab?
  • Is vidutolimod together with cemiplimab safe and well-tolerated?
  • How well does vidutolimod together with cemiplimab treat participants' cancer?

Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.

Official Title

A Multicenter, Open-label, Phase 2 Study of Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Cemiplimab in Subjects With Selected Types of Advanced or Metastatic Cancer

Details

Former Sponsor Checkmate Pharmaceuticals

Keywords

Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer, Oropharynx Squamous Cell Carcinoma, vidutolimod, Metastatic Cancer, Advanced Cancer, MCC, CSCC, BCC, TNBC, NSCLC, OPSCC, Carcinoma, Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Neoplasm Metastasis, Cemiplimab, Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1), Vidutolimod and cemiplimab for CSCC (A2), Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1), Vidutolimod and cemiplimab for MCC (B2), Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1), Vidutolimod and cemiplimab for TNBC (C2), Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D), Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E), Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)

Eligibility

You can join if…

Open to people ages 18 years and up

Participants enrolled in the study must meet all of the following inclusion criteria to be eligible.

  1. Histopathologically-confirmed diagnosis of cancer, as defined by the protocol.
  2. Measurable disease, as defined by RECIST v1.1 and as defined in the protocol. Note: CSCC, MCC and BCC subjects without radiographically measurable disease are not excluded if there is at least 1 lesion ≥ 10 mm in at east 1 dimension documented by color photography.
  3. Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.

You CAN'T join if...

Participants presenting with any of the following will not qualify for entry into the study:

  1. Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.
  2. Had major surgeries (including complete oncologic resection) within last 4 weeks prior to enrollment, and/or have not recovered adequately from the toxicities and/or complications from the intervention. Minor surgeries (including routine resections of early stage CSCCs and BCCs that may be due to field cancerization) require a 7-day washout.
  3. Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 15 days before first dose of study treatment on W1D1, as defined in the protocol.
  4. History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
  5. Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency.
  6. Active pneumonitis or history of noninfectious pneumonitis that required steroids.
  7. Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted.
  8. Known history of immunodeficiency.
  9. Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.
  10. Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
  11. Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037-0845 United States
  • University of California accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04916002
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 225 study participants
Last Updated