A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Sonesitatug Vedotin: Sonesitatug Vedotin will be administered as an IV infusion.

Rilvegostomig: Rilvegostomig will be administered as an IV infusion.

Trastuzumab Deruxtecan (T-DXd): T-DXd will be administered as an IV infusion.

Capecitabine: Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.

5-Fluorouracil (5-FU): 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care.

FLOT Chemotherapy: FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.

Calcium folinate: Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.

Study summary

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

Eligibility

Primary outcome measure(s)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs) — Until sub-study completion, up to 38 months
  To assess the safety and tolerability of perioperative treatment.
• Percentage of participants with pathological complete response (pCR) — Until sub-study completion, up to 38 months
  pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.

Trial sites (70)

+ 30 more sites — see the full list on the official registry below.