| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms Colorectal Neoplasms | Biological: V941 Biological: Pembrolizumab | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1, Open-Label, Multicenter Study to Assess the Safety and Tolerability of mRNA-5671/V941 as a Monotherapy and in Combination With Pembrolizumab in Participants With KRAS Mutant Advanced or Metastatic Non-Small Cell Lung Cancer, Colorectal Cancer or Pancreatic Adenocarcinoma |
| Actual Study Start Date : | June 26, 2019 |
| Estimated Primary Completion Date : | November 19, 2026 |
| Estimated Study Completion Date : | November 19, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: V941 Monotherapy
V941(mRNA-5671/V941) administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
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Biological: V941
V941 administered IM, Q3W for 9 3-week cycles
Other Name: mRNA-5671/V941
|
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Experimental: V941 + Pembrolizumab
V941(mRNA-5671/V941) administered IM Q3W for 9 cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Biological: V941
V941 administered IM, Q3W for 9 3-week cycles
Other Name: mRNA-5671/V941
Biological: Pembrolizumab Pembrolizumab 200 mg, IV for 35 3-week cycles
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part 2 Only
- Has a histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), non-mismatch repair deficient/microsatellite instability-high tumors colorectal cancers (non-MSI-H CRC), or pancreatic adenocarcinoma, and confirmed HLA types HLA-A11:01 and/or HLA C08:02 (and/or potentially other additional HLA types to be specified).
NSCLC: Participants must have been tested for mutations affecting EGFR and/or anaplastic lymphoma kinase (ALK). Participants with ALK or epidermal growth factor receptor (EGFR)-positive NSCLC must have had recurrent or progressive disease (PD) after treatment with the corresponding inhibitor and current standard of care, in any sequence.
Non-MSI-H CRC: Participant tumors must have been locally tested for MSI and have been found to be non-MSI-H.
All
Exclusion Criteria:
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Show 24 study locations
| Study Director: | Medical Director, MD | Merck Sharp & Dohme Corp. |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 10, 2019 | ||||||
| First Posted Date ICMJE | May 14, 2019 | ||||||
| Last Update Posted Date | May 13, 2021 | ||||||
| Actual Study Start Date ICMJE | June 26, 2019 | ||||||
| Estimated Primary Completion Date | November 19, 2026 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures |
T-cell receptor (TCR) [ Time Frame: Up to approximately 24 months ] T-cell receptor (TCR) clonality and diversity in the periphery and tumor.
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| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) | ||||||
| Official Title ICMJE | A Phase 1, Open-Label, Multicenter Study to Assess the Safety and Tolerability of mRNA-5671/V941 as a Monotherapy and in Combination With Pembrolizumab in Participants With KRAS Mutant Advanced or Metastatic Non-Small Cell Lung Cancer, Colorectal Cancer or Pancreatic Adenocarcinoma | ||||||
| Brief Summary | This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
100 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | November 19, 2026 | ||||||
| Estimated Primary Completion Date | November 19, 2026 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Part 2 Only - Has a histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), non-mismatch repair deficient/microsatellite instability-high tumors colorectal cancers (non-MSI-H CRC), or pancreatic adenocarcinoma, and confirmed HLA types HLA-A11:01 and/or HLA C08:02 (and/or potentially other additional HLA types to be specified). NSCLC: Participants must have been tested for mutations affecting EGFR and/or anaplastic lymphoma kinase (ALK). Participants with ALK or epidermal growth factor receptor (EGFR)-positive NSCLC must have had recurrent or progressive disease (PD) after treatment with the corresponding inhibitor and current standard of care, in any sequence. Non-MSI-H CRC: Participant tumors must have been locally tested for MSI and have been found to be non-MSI-H. All
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Australia, Hong Kong, Korea, Republic of, Singapore, Taiwan, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03948763 | ||||||
| Other Study ID Numbers ICMJE | V941-001 V941-001 ( Other Identifier: Merck Protocol Number ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Merck Sharp & Dohme Corp. | ||||||
| Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Merck Sharp & Dohme Corp. | ||||||
| Verification Date | May 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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