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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04916002
• Other study ID #: CMP-001-009
• Secondary ID: 2023-507344-36-0
• Status: Suspended
• Phase: Phase 2
• Start date: November 30, 2021
• Est. completion date: July 29, 2027

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Former Sponsor Checkmate Pharmaceuticals

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 225
• Est. completion date: July 29, 2027
• Est. primary completion date: July 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Merkel Cell
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma
• Merkel Cell Carcinoma
• Neoplasm Metastasis
• Non-Small Cell Lung Cancer
• Oropharynx Squamous Cell Carcinoma
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• vidutolimod
Participants will receive vidutolimod for up to 2 years as follows: 10 mg IT weekly for 7 doses after which vidutolimod will be administered every 3 weeks (Q3W). The first dose of vidutolimod may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of vidutolimod, delivered on a weekly dosing schedule, must be completed before starting the Q3W vidutolimod dosing schedule.
• cemiplimab
Participants will receive cemiplimab for up to 2 years as follows: 350 mg IV infusion over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Australia	Peter MacCallum Cancer Centre (PMCC) and The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	East Carolina University	Greenville	North Carolina
United States	Oncology Consultants	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	GenesisCare USA	Jacksonville	Florida
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Dartmouth Clinical Trial Office	Lebanon	New Hampshire
United States	University of California	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Orlando Health Cancer Institute	Orlando	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Utah Huntsman Cancer Center	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) with vidutolimod in combination with cemiplimab in study participants with metastatic or advanced/unresectable CSCC, MCC, BCC, NSCLC,TNBC or OPSCC	CSCC is defined as cutaneous squamous cell carcinoma, MCC is defined as Merkel cell carcinoma, BCC is defined as Basal cell carcinoma, NSCLC is defined as Non-small cell lung cancer, TNBC is defined as triple negative breast cancer and OPSCC is defined as oropharyngeal squamous cell carcinoma. ORR is further defined as the proportion of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1.)	Up to 42 Months
Secondary	Safety and tolerability of vidutolimod administered by IT injection in combination with cemiplimab in the study participants	Safety and tolerability is defined as the presence of Adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)	Up to 42 Months
Secondary	Efficacy of vidutolimod in combination with cemiplimab in the study participants	Efficacy is measured by: Duration of response (DOR), defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1 Response in injected and noninjected target lesions per RECIST v1.1. Progression-free survival (PFS), defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first. Overall survival (OS), defined as the time from date of first dose of study treatment to date of death	Up to 42 Months