Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive up to 5 escalating dose levels (1 milligram \[mg\], 3 mg, 5 mg, 7.5 mg and 10 mg) of CMP-001 via intratumoral injection according to one of 2 schedules (Schedule A: once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued; Schedule B: once weekly for 2 weeks, followed by every 3 weeks thereafter until participant is discontinued) in combination with pembrolizumab at its labelled dose and schedule.

Participants will receive CMP-001 10 mg via intratumoral injection by Schedule A (once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued) in combination with pembrolizumab at its labelled dose and schedule. As of 05 October 2018, the dose and schedule for Part 1 Dose Expansion Phase was selected based on all available safety, efficacy and pharmacodynamic data from the Part 1 Dose Escalation Phase. Participants who were enrolled prior to 05 October 2018 to receive CMP-001 doses less than (\<) 10 mg will have the option to receive CMP-001 doses up to 10 mg on Schedule A in combination with pembrolizumab.

Participants will receive CMP-001 10 mg via intratumoral injection by Schedule A (once weekly for 7 weeks, followed by every 3 weeks thereafter until participant is discontinued). Participants who were enrolled prior to 05 October 2018 to receive CMP-001 doses \<10 mg will have the option to receive CMP-001 doses up to 10 mg on Schedule A. Participants with documented progression while on CMP-001 monotherapy treatment will have the option to crossover to the combination treatment of CMP-001 10 mg plus pembrolizumab, at the discretion of the Investigator.

CMP-001 will be administered as per the dose and schedule specified in the respective arms.

CMP-001

Pembrolizumab will be administered as per the schedule specified in the respective arms.

Clinical Trial Management

This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy. A Treatment Extension to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy will be available to those who are currently being treated in either Part 1 or Part 2 of this study at the time of protocol Amendment 9, v10.0.

Former Sponsor Checkmate Pharmaceuticals

The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with pembrolizumab in participants with advanced melanoma.

The primary objective of Part 2 of the study is to assess and describe the safety profile of CMP-001 when administered as monotherapy.

The primary objective of the Treatment Extension is to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy in the Treatment Extension.

Participants enrolled into either Part 1 or Part 2 will continue study treatment as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator. Participants may continue therapy beyond progression based upon Investigator judgement of potential benefit.

Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy

A Multicenter, Two Part Open-Label, Phase 1B Clinical Study of CMP-001 Administered Either in Combination With Pembrolizumab or as a Monotherapy in Subjects With Advanced Melanoma

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

TEAEs will be evaluated and assigned a grade using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

TEAEs will be evaluated and assigned a grade using CTCAE version 5.0

Oral temperature should be measured in supine or seated position, following at least 30 minutes of rest.

Respiratory rate should be measured in supine or seated position, following at least 30 minutes of rest.

Blood pressure should be measured in supine or seated position, following at least 30 minutes of rest.

Physical examination included body weight measurement.

Physical examination included BMI measurement.

ECG parameters will include heart rate and PR, QRS, QT, and QT corrected for heart rate (QTc) intervals. QT will be corrected using Fridericia's (QTcF) formula. ECG will be performed after the participant has been resting in supine or semi-supine position for at least 5 minutes.

Clinical laboratory parameters includes serum chemistry, hematology, and urinalysis.

ORR will be calculated as the number of participants with a confirmed complete response (CR) or partial response (PR) divided by the number of participants dosed.

BOR will be calculated as the number of participants with best response of CR or PR divided by the number of participants dosed.

Regeneron Pharmaceuticals

Nivolumab

All enrolled subjects will receive CMP-001 IT and nivolumab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

All enrolled subjects will receive nivolumab monotherapy IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).

CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma.

The study is divided into two phases: Phase 2 and Phase 3.

The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma.

The secondary objectives of Phase 3 are to:

* To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
* To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.

CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma

A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma

Objective response rate (ORR) is defined as proportion of subjects 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) as determined by Blinded Independent Central Review (BICR).

Progression-free survival (PFS) is defined as time from date of randomization to first date of documented progressive disease based on RECIST v1.1 by BICR or death (from any cause, whichever occurs first).

Defined by adverse events (AEs), serious adverse events (SAEs), \& AEs leading to discontinuation or death \& severity of AEs as assessed by NCI CTCAE version 5.0.

The time from the date of randomization to the date of death due to any cause.

The proportion of subjects with a confirmed objective response of CR or PR based on RECIST v1.1 as determined by BICR.

The time from date of first documented response (CR or PR) to date of documented progressive disease, based on RECIST v1.1 as determined by BICR.

The proportion of subjects with confirmed best response of CR or PR, or stable disease lasting at least 4 months, based on RECIST v1.1 as determined by BICR.

The confirmed ORR in non-injected target lesions based on the RECIST v1.1. Treatment response in non-injected lesions based on RECIST v1.1 by investigator assessment (IA).

The time from date of first dose of study drug to date of iCPD by IA or death, whichever occurs first.

The time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA.

The proportion of subjects with a best overall response of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA.

Bristol-Myers Squibb

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Infections

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Basal Cell

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Breast Diseases

Neoplastic Processes

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Adenocarcinoma

Merkel Cell Carcinoma

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Antibodies

Trastuzumab

Sacituzumab govitecan

Trastuzumab deruxtecan

Cemiplimab

Immunoglobulins

Mitogens

Antibodies, Blocking

Adenosine

Poly(ADP-ribose) Polymerase Inhibitors

Participants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable CSCC and who are not eligible for curative radiation will receive vidutolimod intratumoral(ly) (IT) and cemiplimab intravenous (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have progressed while receiving a programmed cell death protein 1 (PD-1)-blocking antibody or within 12 weeks of discontinuation of PD-1 blocking antibody for metastatic or locally and/or regionally advanced unresectable CSCC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable MCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of the PD-1 blocking antibody, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have not received prior therapy with immune checkpoint inhibitors (iCPIs) and who must have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan \[human epidermal growth factor receptor 2 (HER2)-low participants\] and with adenosine diphosphate ribose polymerase (PARP) inhibitor \[for BReast CAncer gene (BRCA)\] for TNBC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan (HER2-low participants) and with PARP inhibitor (for BRCA) and who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of a PD-1 blocking antibody for advanced or metastatic TNBC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants who have not received prior hedgehog pathway inhibitor therapy, or prior anti-PD-1/programmed cell death ligand 1 (PD-L1) therapy and who do not wish to receive or who are not candidates for a hedgehog inhibitor, for metastatic or locally and/or regionally advanced unresectable BCC and will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

Participants with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression \[tumor proportion score (TPS) ≥50%\] based on a prior PD-L1 result as determined by College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed) lab, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ros oncogene 1 (ROS1) aberrations, and who have not received prior anti-PD-1/PD-L1 therapy and are amenable to IT therapy and do not wish to receive chemotherapy.

Note: this cohort is not conducted in Europe

Participants with PD-L1 combined positive score (CPS) ≥ 1, based on a prior PD-L1 result and human papillomavirus (HPV)-positive disease based on a prior result, who have not received prior systemic therapy for recurrent/metastatic disease. Participants will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.

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.

vidutolimod

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.

cemiplimab

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.

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

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

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.)

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)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy	NCT02680184	Melanoma	CMP-001 Pembrolizumab	18 Years -	Regeneron Pharmaceuticals
CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma	NCT04695977	Melanoma Advanced Melano... Metastatic Mela... Unresectable Me...	CMP-001 Nivolumab	18 Years -	Regeneron Pharmaceuticals
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	NCT04916002	Merkel Cell Car... Cutaneous Squam... Basal Cell Carc... Triple Negative... Non-Small Cell ... Oropharynx Squa...	vidutolimod cemiplimab	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for vidutolimod

Every month we try and update this database with for vidutolimod cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vidutolimod

Every month we try and update this database with for vidutolimod cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vidutolimod cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.