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

NOT ENROLLING
Protocol # :
21-606
Conditions
Merkel Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
Triple Negative Breast Cancer
Non-Small Cell Lung Cancer
Oropharynx Squamous Cell Carcinoma
Phase
II
Disease Sites
Other Skin
Breast
Principal Investigator
Silk, Ann, Willman
Site Research Nurses
Harran, John
Liao, Zixi

Trial Description

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.

Eligibility 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. 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.

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. 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

21-606