Trial Title:
A Study of Pembrolizumab (MK-3475) With or Without V940 in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
NCT ID:
NCT06623422
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Cisplatin
Carboplatin
Gemcitabine
Pembrolizumab
Pemetrexed
Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Individualized neoantigen therapy (INT)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV Infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
MK-3475
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
IV infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
Platinol®
Other name:
Platinol®-AQ
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
Paraplatin®
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
IV infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
Alimta®
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
IV infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
Gemzar
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV infusion
Arm group label:
Pembrolizumab + Placebo
Arm group label:
Pembrolizumab + V940
Other name:
Taxol®
Other name:
Onxol®
Intervention type:
Biological
Intervention name:
V940
Description:
IM injection
Arm group label:
Pembrolizumab + V940
Other name:
mRNA-4157
Intervention type:
Other
Intervention name:
Placebo
Description:
IM injection
Arm group label:
Pembrolizumab + Placebo
Summary:
The goal of this study is to learn if people who receive V940 and pembrolizumab after
surgery are cancer-free longer than people who receive placebo and pembrolizumab.
Researchers want to know if giving V940 and pembrolizumab after surgery can help prevent
the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose
tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has histologically/cytologically confirmed diagnosis of previously untreated and
pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung
cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within
7 days before the first dose of study intervention
- Participants who have not achieved a pathological complete response (pCR) following
completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be
eligible
- Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not
indicated as primary therapy (documentation of absence of tumor-activating EGFR
mutations [eg, DEL19 or L858R])
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on anti-retroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if
they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks
and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a
neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a
pancoast tumor
- Documentation by local test report indicating presence of anaplastic lymphoma kinase
(ALK) gene rearrangements
- Received prior neoadjuvant therapy for their current NSCLC diagnosis
- Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed
cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent,
or with an agent directed to another stimulatory or coinhibitory T-cell receptor
(eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
- Received prior systemic anticancer therapy including investigational agents other
than what is specified in this protocol
- Received prior treatment with a cancer vaccine
- Received prior radiotherapy within 2 weeks of start of study intervention, or has
radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beacon Cancer Care ( Site 0127)
Address:
City:
Post Falls
Zip:
83854
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
208-755-2408
Facility:
Name:
Thompson Cancer Survival Center ( Site 0168)
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
865-331-1720
Facility:
Name:
Tasman Oncology Research ( Site 2104)
Address:
City:
Southport
Zip:
4215
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+61 7 5613 2480
Facility:
Name:
McGill University Health Centre ( Site 1103)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5149341934
Facility:
Name:
Rambam Health Care Campus ( Site 1603)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+97247772688
Facility:
Name:
Shaare Zedek Medical Center ( Site 1601)
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+97226555999
Start date:
October 21, 2024
Completion date:
January 26, 2038
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
ModernaTX, Inc.
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06623422
https://www.merckclinicaltrials.com/
