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A Trial to Find Out if Vidutolimod Together With Cemiplimab is Safe and if it Works in Adult Participants With Advanced Cancer or Metastatic Cancer

Sponsored by Regeneron Pharmaceuticals

About this trial

Last updated 2 years ago

Study ID

CMP-001-009

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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 an end of treatment visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.

What are the Participation Requirements?

Key Inclusion Criteria:

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.

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.

Key Exclusion Criteria:

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. Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within
30 days before first dose of study treatment on W1D1, as defined in the protocol.

3. History of immune-mediated AE leading to permanent discontinuation due to prior
PD-1-blocking antibody.

4. 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.

5. Active pneumonitis or history of noninfectious pneumonitis that required steroids.

6. 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.

7. Known history of immunodeficiency.

8. Known additional malignancy that is progressing or required active treatment within
the past 3 years, as defined in the protocol.

9. Active autoimmune disease that required systemic treatment in past 2 years;
replacement therapy is not considered a form of systemic treatment.

10. 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

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Completed
Completed