Trial Title:
Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
NCT ID:
NCT06445972
Condition:
Gastroesophageal Junction
Gastroesophageal Adenocarcinoma
Esophageal Neoplasms
Esophageal Cancer
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Ramucirumab
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:
Ramucirumab
Description:
8 mg/kg IV Infusion
Arm group label:
Ramucirumab + Paclitaxel
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
80 mg/M^2 IV infusion
Arm group label:
MK-2870 + Paclitaxel
Arm group label:
Ramucirumab + Paclitaxel
Intervention type:
Biological
Intervention name:
MK-2870
Description:
3 mg/kg or 4 mg/kg IV Infusion
Arm group label:
MK-2870 + Paclitaxel
Other name:
SKB264
Other name:
sacituzumab tirumotecan
Other name:
sac-TMT
Summary:
This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate
the safety and efficacy of MK-2870 plus paclitaxel versus Ramucirumab plus paclitaxel,
for the treatment of participants with advanced or metastatic gastric adenocarcinoma,
gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have
failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis
testing will be performed.
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 treated,
2L (received first line (1L) treatment) gastric adenocarcinoma, GEJ adenocarcinoma,
or esophageal adenocarcinoma
- Has metastatic disease or locally advanced, unresectable disease
- Has experienced documented objective radiographic or clinical disease progression
during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or
without immunotherapy
- Has gastroesophageal adenocarcinoma that is not human epidermal growth factor
receptor 2 (HER2)/neu positive
- Can provide an archival tumor tissue sample or most recently obtained core,
incisional, or excisional biopsy of a tumor lesion
- AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except
alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone
replacement are acceptable.
- Has Eastern Cooperative Oncology Group performance status of 0 or 1
- Has a life expectancy of at least 3 months
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has squamous cell or undifferentiated esophageal gastric cancer
- Has experienced weight loss >20% over 3 months before the first dose of study
intervention
- Has 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 a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days
prior to randomization
- Has a bowel obstruction, history or presence of inflammatory enteropathy or
extensive intestinal resection (hemicolectomy or extensive small intestine resection
with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has experienced any arterial thrombotic event, including myocardial infarction,
unstable angina, cerebrovascular accident, or transient ischemic attack, within 6
months prior to randomization
- Has uncontrolled arterial hypertension ≥150/≥90 mm Hg
- Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or
diuretic drugs within 2 weeks prior to enrollment
- Has undergone major surgery within 28 days prior to randomization, or central venous
access device placement within 7 days prior to randomization or planned major
surgery following initiation of study treatment
- Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin
or similar agents
- Is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs) or
other antiplatelet agents
- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant
thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis
are not considered "significant") during the 3 months prior to randomization
- Has significant bleeding disorders, vasculitis, or had a significant bleeding
episode from the gastrointestinal (GI) tract within 3 months prior to study entry
- Has history of GI perforation and/or fistulae within 6 months prior to randomization
- Has a history of human immunodeficiency virus (HIV) infection
- Has received prior systemic anticancer therapy including investigational agents
within 4 weeks before the first dose of study drug intervention
- 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. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the
bladder, that have undergone potentially curative therapy are not excluded.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has an active infection requiring systemic therapy
- Has a concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg)
positive and/or detectable hepatitis B virus deoxyribonucleic acid (HBV DNA)) and
Hepatitis C virus (defined as anti-hepatitis C virus antibody (HCV Ab) positive and
detectable HCV ribonucleic acid (RNA)) infection
- Has severe hypersensitivity (Grade ≥3) to MK-2870, any of its excipients and/or to
another biologic therapy
- Has 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 Cancer Institute - Downtown ( Site 8900)
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-933-3316
Facility:
Name:
Cancer and Hematology Centers of Western Michigan ( Site 8912)
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 8925)
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 8400)
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 8404)
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 8405)
Address:
City:
Santiago
Zip:
7620002
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56991290140
Facility:
Name:
Beijing Cancer hospital-Digestive Oncology ( Site 7500)
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 7901)
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 7900)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82234101795
Facility:
Name:
Oslo universitetssykehus, Radiumhospitalet ( Site 8501)
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4723026600
Facility:
Name:
Hôpitaux Universitaires de Genève (HUG) ( Site 8701)
Address:
City:
Genève
Zip:
1211
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41223729861
Facility:
Name:
Kantonsspital Graubünden-Medizin ( Site 8700)
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41812566884
Start date:
August 7, 2024
Completion date:
October 27, 2028
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/NCT06445972
https://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-06D&&kw=3475-06D
