Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

Conditions

• Esophageal Cancer
• Esophageal Neoplasms
• Gastroesophageal Adenocarcinoma
• Gastroesophageal Junction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ramucirumab — BIOLOGICAL
  8 mg/kg IV Infusion
• Paclitaxel — DRUG
  80 mg/M\^2 IV infusion
• Sacituzumab Tirumotecan — BIOLOGICAL
  3 mg/kg or 4 mg/kg IV Infusion
• Rescue Medications — DRUG
  Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.
• HER3-DXd — BIOLOGICAL
  IV Infusion

Study Details

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab 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.

Key Dates

Start date

Aug 7, 2024

Status verified

May 2026

Primary completion

May 9, 2028

Completion

Aug 8, 2030

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Ramucirumab + Paclitaxel
  Participants receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) until discontinuation.
• Experimental: Sacituzumab Tirumotecan + Paclitaxel
  Following a 28-day run-in with sacituzumab tirumotecan at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) plus sacituzumab tirumotecan at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation.
• Experimental: HER3-DXd + Ramucirumab
  Participants receive HER3-DXd via IV infusion on days 1 and 22 of each 6-week cycle plus ramucirumab at 8mg/kg via IV infusion on days 1 and 15 and 29 of each 6-week cycle until discontinuation.

Primary Outcome Measure

Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase [ Time Frame: Up to ~28 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (8)

Find similar trials in Tucson, AZ

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