Lung Cancer Clinical Trial

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

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.

View Eligibility Criteria

Eligibility Criteria

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

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.
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.

Exclusion Criteria:

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).
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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT03948763

Recruitment Status:

Completed

Sponsor:

Merck Sharp & Dohme LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 24 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center ( Site 1008)
Gilbert Arizona, 85234, United States
City of Hope ( Site 1002)
Duarte California, 91010, United States
University of California at San Francisco ( Site 1006)
San Francisco California, 30322, United States
Smilow Cancer Hospital at Yale New Haven ( Site 1005)
New Haven Connecticut, 06510, United States
Dana-Farber Cancer Institute (Boston) ( Site 1007)
Boston Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada ( Site 1012)
Las Vegas Nevada, 89169, United States
Tennessee Oncology Nashville Drug Development Unit ( Site 7000)
Nashville Tennessee, 37203, United States
START San Antonio ( Site 1004)
San Antonio Texas, 78229, United States
Baylor Scott & White Medical Center - Temple ( Site 1009)
Temple Texas, 76508, United States
Northwest Medical Specialties, PLLC ( Site 1001)
Tacoma Washington, 98405, United States
Kinghorn Cancer Centre ( Site 6000)
Darlinghurst New South Wales, 2010, Australia
Southern Oncology Clinical Research Unit SOCRU ( Site 6002)
Bedford Park South Australia, 5042, Australia
Monash Health-Monash Medical Centre ( Site 6001)
Clayton Victoria, 3168, Australia
Prince of Wales Hospital ( Site 2002)
Hong Kong , , Hong Kong
Queen Mary Hospital ( Site 2001)
Hong Kong , , Hong Kong
Asan Medical Center ( Site 0802)
Songpagu Seoul, 05505, Korea, Republic of
Seoul National University Hospital ( Site 0801)
Seoul , 03080, Korea, Republic of
Severance Hospital ( Site 0800)
Seoul , 03722, Korea, Republic of
New Zealand Clinical Research (Christchurch) ( Site 6501)
Christchurch Canterbury, 8011, New Zealand
Auckland City Hospital ( Site 6500)
Auckland , 1023, New Zealand
National University Hospital ( Site 3006)
Singapore Central Singapore, 11907, Singapore
National Cancer Centre Singapore ( Site 3005)
Singapore Central Singapore, 16961, Singapore
Tan Tock Seng Hospital ( Site 3007)
Singapore Central Singapore, 39844, Singapore
National Cheng Kung University Hospital ( Site 4002)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 4000)
Taipei , 10002, Taiwan
Taipei Veterans General Hospital ( Site 4001)
Taipei , 11217, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT03948763

Recruitment Status:

Completed

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.