NeoplasmsPhase 1NCT03948763
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
A Phase 1 study testing V941 and Pembrolizumab in people with Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 26 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
- What is being tested?
- V941 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 26 Jun 2019to 25 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has a histologically confirmed advanced or metastatic KRAS 4MUT+ (G12D, G12V, G13D or G12C) (4 prevalent KRAS mutant antigens in solid tumors) solid tumor identified by local laboratory testing, and who have received, or been intolerant to, or ineligible for all treatment known to confer clinical benefit.
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- A male participant must agree to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
- A female participant was not be pregnant, not breastfeeding, and at not be a woman of childbearing potential (WOCBP) OR if a WOCBP, agrees to follow study-approved contraceptive guidance during treatment period and for at least 120 days after the last dose of study intervention.
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- For Part 1 only: Cutaneous lesions can be considered in addition to imaging, but measurable disease should be defined by radiologic assessment.
- Have an evaluable archival tumor sample to submit for analysis. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
- Have adequate organ function
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation
- Has an active infection requiring therapy.
- Has a history of interstitial lung disease.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.
- Has not fully recovered from any effects of major surgery or has evidence of detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study treatment administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study treatment administration and participants should be recovered.
- Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, non-cytotoxic small molecule therapeutics within 5 half-lives (or 2 weeks, whichever is longer) prior to the first dose of study treatment, or has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related adverse events).
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- Has received a live-virus vaccine within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- Has received hematopoietic colony-stimulating growth factors (eg, granulocyte-colony stimulating factor, granulocyte-macrophage-colony stimulating factor, macrophage colony stimulating factor) within 2 weeks prior to the first dose of study intervention.
- Discontinued from therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR; eg, cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), CD137 (4-1BB, Tumor necrosis factor-receptor superfamily 9 [TNFSF9]), and OX 40 (TNFRSF4), due to a Grade 3 or higher immune-related adverse event (irAE).
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection.
- Has a known history of HIV.
- Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
United States10 sites
Dana-Farber Cancer Institute (Boston) ( Site 1007)
Boston, Massachusetts, 02215
City of Hope ( Site 1002)
Duarte, California, 91010
Banner MD Anderson Cancer Center ( Site 1008)
Gilbert, Arizona, 85234
Comprehensive Cancer Centers of Nevada ( Site 1012)
Las Vegas, Nevada, 89169
Tennessee Oncology Nashville Drug Development Unit ( Site 7000)
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale New Haven ( Site 1005)
New Haven, Connecticut, 06510
START San Antonio ( Site 1004)
San Antonio, Texas, 78229
University of California at San Francisco ( Site 1006)
San Francisco, California, 30322
Northwest Medical Specialties, PLLC ( Site 1001)
Tacoma, Washington, 98405
Baylor Scott & White Medical Center - Temple ( Site 1009)
Temple, Texas, 76508
Australia3 sites
Southern Oncology Clinical Research Unit SOCRU ( Site 6002)
Bedford Park, South Australia, 5042
Monash Health-Monash Medical Centre ( Site 6001)
Clayton, Victoria, 3168
Kinghorn Cancer Centre ( Site 6000)
Darlinghurst, New South Wales, 2010
Singapore3 sites
National University Hospital ( Site 3006)
Singapore, Central Singapore, 119074
National Cancer Centre Singapore ( Site 3005)
Singapore, Central Singapore, 169610
Tan Tock Seng Hospital ( Site 3007)
Singapore, Central Singapore, 398442
South Korea3 sites
Seoul National University Hospital ( Site 0801)
Seoul, 03080
Severance Hospital ( Site 0800)
Seoul, 03722
Asan Medical Center ( Site 0802)
Songpagu, Seoul, 05505
Taiwan3 sites
National Cheng Kung University Hospital ( Site 4002)
Tainan, 704
National Taiwan University Hospital ( Site 4000)
Taipei, 10002
Taipei Veterans General Hospital ( Site 4001)
Taipei, 11217
Hong Kong2 sites
Prince of Wales Hospital ( Site 2002)
Hong Kong
Queen Mary Hospital ( Site 2001)
Hong Kong
New Zealand2 sites
Auckland City Hospital ( Site 6500)
Auckland, 1023
New Zealand Clinical Research (Christchurch) ( Site 6501)
Christchurch, Canterbury, 8011
About this study
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
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.
- Being tested
- V941, Pembrolizumab
- Keywords
- cancer, solid tumors, therapeutic vaccine, Pembrolizumab, PD1, PD-1, PDL1, PD-L1, KRAS, mRNA
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V941Biological
Also called mRNA-5671/V941
V941 administered IM, Q3W for 9 3-week cycles
PembrolizumabBiological
Also called MK-3475
Pembrolizumab 200 mg, IV for 35 3-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Part 1: V941 Monotherapy | Experimental | V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles Receives: Biological: V941 |
| Part 1: V941 + Pembrolizumab | Experimental | V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles Receives: Biological: V941; Biological: Pembrolizumab |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | Experimental | V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles Receives: Biological: V941; Biological: Pembrolizumab |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | Experimental | V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles Receives: Biological: V941; Biological: Pembrolizumab |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | Experimental | V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles Receives: Biological: V941; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs)
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.
Measured: Cycle 1 (Up to 21 days)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to approximately 27 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study treatment due to an AE is reported.
Measured: Up to approximately 24 months
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.
Measured: Up to approximately 24 months
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.
Measured: Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Mean change from baseline in the quantity of mutant KRAS specific T cells in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10^6 PBMC. The mean change is reported.
Measured: Baseline and Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start26 Jun 2019
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ModernaTX, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp and Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948763
- Sponsor's protocol ID
- V941-001
- Other IDs
- V941-001
- Status last verified
- Jan 2025
- First submitted
- 10 May 2019
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03948763
- Acronym / sponsor ID
- V941-001
- Keywords
- cancer, solid tumors, therapeutic vaccine, Pembrolizumab, PD1, PD-1, PDL1, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- ModernaTX, Inc.
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: V941 Monotherapy | Experimental | Biological: V941V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles |
| Part 1: V941 + Pembrolizumab | Experimental | Biological: V941, Biological: PembrolizumabV941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | Experimental | Biological: V941, Biological: PembrolizumabV941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | Experimental | Biological: V941, Biological: PembrolizumabV941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | Experimental | Biological: V941, Biological: PembrolizumabV941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (20 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation
- Has an active infection requiring therapy.
- Has a history of interstitial lung disease.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.
- Has not fully recovered from any effects of major surgery or has evidence of detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study treatment administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study treatment administration and participants should be recovered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V941Also: mRNA-5671/V941V941 administered IM, Q3W for 9 3-week cycles | Biological | Part 1: V941 + Pembrolizumab, Part 1: V941 Monotherapy, Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab), Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab), Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) |
| PembrolizumabAlso: MK-3475Pembrolizumab 200 mg, IV for 35 3-week cycles | Biological | Part 1: V941 + Pembrolizumab, Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab), Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab), Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) |
Primary outcome
Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Up to 21 days)
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 27 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to approximately 24 months
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study treatment due to an AE is reported.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Time frame: Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Time frame: Baseline and Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp and Dohme LLC
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V941 and Pembrolizumab in people with Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, Singapore, South Korea, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (Up to 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.