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Trial Title:
Substudy 06C: A Study of Sacituzumab Tirumotecan (MK-2870) With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
NCT ID:
NCT06469944
Condition:
Gastroesophageal Junction
Gastroesophageal Adenocarcinoma
Esophageal Neoplasms
Esophageal Cancer
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Calcium, Dietary
Leucovorin
Pembrolizumab
Capecitabine
Calcium
Levoleucovorin
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)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Administered via intravenous (IV) infusion.
Arm group label:
Pembrolizumab plus Chemotherapy
Arm group label:
Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Other name:
MK-3475
Other name:
Keytruda®
Intervention type:
Biological
Intervention name:
Sacituzumab Tirumotecan
Description:
Administered via IV infusion.
Arm group label:
Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Other name:
MK-2870
Other name:
SKB264
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Administered via oral tablet.
Arm group label:
Pembrolizumab plus Chemotherapy
Arm group label:
Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Other name:
XELODA
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Administered via IV infusion.
Arm group label:
Pembrolizumab plus Chemotherapy
Other name:
calcium folinate
Other name:
folinic acid
Other name:
WELLCOVORIN®
Intervention type:
Drug
Intervention name:
Levoleucovorin
Description:
Administered via IV infusion.
Arm group label:
Pembrolizumab plus Chemotherapy
Other name:
calcium levofolinate
Other name:
levofolinic acid
Other name:
FUSILEV®
Intervention type:
Drug
Intervention name:
5-FU
Description:
Administered via IV infusion
Arm group label:
Pembrolizumab plus Chemotherapy
Arm group label:
Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy
Other name:
ADRUCIL®
Summary:
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate
the safety and tolerability of sacituzumab tirumotecan with pembrolizumab and
fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with
locally advanced unresectable or metastatic human epidermal growth factor receptor 2
(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The
safety lead-in phase will be used to evaluate the safety and tolerability, and to
establish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combination
with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
Detailed description:
The master protocol is MK-3475-U06.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has histologically and/or cytologically confirmed diagnosis of previously untreated
locally advanced unresectable or metastatic 1L gastroesophageal adenocarcinoma
- Is not expected to require tumor resection during the treatment course- Has not had
prior systemic therapy administered in the recurrent or metastatic setting
- Has gastroesophageal adenocarcinoma that is not human epidermal growth factor
receptor 2 (HER2)/neu positive
- Has provided an archival tumor tissue sample or most recently obtained core, or
incisional, or excisional biopsy for a tumor lesion
- Participants who have adverse events (AEs) due to previous anticancer therapies must
have recovered to 20% over 3 months before the first dose of study
intervention
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease
and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has Grade >2 peripheral neuropathy
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
within 6 months preceding study intervention
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or
diuretic drugs within 2 weeks prior to enrollment
- Has history of human immunodeficiency virus (HIV) infection
- Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted
antibody-drug conjugate (ADC)
- Has received prior treatment with a topoisomerase 1 inhibitor-based ADC and/or a
topoisomerase 1 inhibitor-based chemotherapy
- Has received prior systemic anticancer therapy including investigational agents
within 4 weeks before the first dose of study intervention
- Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1),
anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2
(PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (TCR)
- Has received prior radiotherapy within 2 weeks of start of study intervention, or
has radiation related toxicities, requiring corticosteroids
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention
- Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study intervention
- Has known additional malignancy that is progressing or has required active treatment
within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
-
20. Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab
tirumotecan, or other biologic therapy, chemotherapy (ie, oxaliplatin,
fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their
excipients
- Has active autoimmune disease that has required systemic treatment in the past 2
years
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) and/or hepatitis C (defined as anti-hepatitis C virus [HCV] Ab positive
and detectable HCV ribonucleic acid [RNA] infection or a known history of hepatitis
B and/or C infection
- Has GI obstruction, poor oral intake, or difficulty in taking oral medication
- Has poorly controlled diarrhea
- Has had a major surgery or significant traumatic injury within 4 weeks before the
first dose of study intervention
- Has history of allogeneic tissue/solid organ transplant
- Have not adequately recovered from major surgery or have ongoing surgical
complications
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
502-394-6350
Facility:
Name:
Cancer and Hematology Centers of Western Michigan ( Site 6912)
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
269-993-6056
Facility:
Name:
Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
Address:
City:
East Syracuse
Zip:
13057
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
315-472-7504
Facility:
Name:
FALP-UIDO ( Site 6400)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Centro de Oncología de Precisión-Oncology ( Site 6404)
Address:
City:
Santiago
Zip:
7560908
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56991612199
Facility:
Name:
Clínica UC San Carlos de Apoquindo ( Site 6405)
Address:
City:
Santiago
Zip:
7620002
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56991290140
Facility:
Name:
Beijing Cancer hospital-Digestive Oncology ( Site 5500)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8601088196340
Facility:
Name:
Asan Medical Center-Department of Oncology ( Site 5901)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230103217
Facility:
Name:
Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82234101795
Facility:
Name:
Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4723026600
Facility:
Name:
Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
Address:
City:
Genève
Zip:
1211
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41223729861
Facility:
Name:
Kantonsspital Graubünden-Medizin ( Site 6700)
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41812566884
Start date:
September 20, 2024
Completion date:
April 12, 2029
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
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/NCT06469944
https://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-06C&kw=3475-06C
