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

ConditionGastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease

Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ and bone marrow function

Disqualifiers

Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.

Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment

Central nervous system (CNS) pathology

Uncontrolled infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sonesitatug Vedotin

    Drug

    Sonesitatug Vedotin will be administered as an IV infusion.

  • Rilvegostomig

    Drug

    Rilvegostomig will be administered as an IV infusion.

  • Trastuzumab Deruxtecan (T-DXd)

    Drug

    T-DXd will be administered as an IV infusion.

  • Capecitabine

    Drug

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

  • 5-Fluorouracil (5-FU)

    Drug

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

  • FLOT Chemotherapy

    Drug

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

  • Calcium folinate

    Drug

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

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or CapecitabineExperimental treatment 4 interventions
Group B: Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or CapecitabineExperimental treatment 4 interventions
Group C: Sub-study 3: Rilvegostomig plus FLOT chemotherapyExperimental treatment 2 interventions
Group D: Sub-study 1: Cohort 1b - Sonesitatug Vedotin plus Rilvegostomig and CapecitabineExperimental treatment 3 interventions
Group E: Sub-study 1: Cohort 1c - Sonesitatug Vedotin plus Rilvegostomig plus 5-FU and calcium folinateExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

To assess the safety and tolerability of perioperative treatment.

Time frame
Until sub-study completion, up to 38 months
2

Percentage of participants with pathological complete response (pCR)

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.

Time frame
Until sub-study completion, up to 38 months

Secondary outcomes

1

Surgery completion rate

Surgery completion rate is defined as the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy.

Time frame
Until sub-study completion, up to 38 months
2

R0 resection (complete resection) rate

R0 resection (complete resection) rate is the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy and had a confirmed margin-negative resection.

Time frame
Until sub-study completion, up to 38 months
3

Percentage of participants with tumor downstaging

Tumor downstaging is defined as the lowering of the primary tumor (T) and/or regional lymph nodes (N) from pre-neoadjuvant clinical staging (pre-cTN) to post-neoadjuvant clinical staging (post-cTN) and to postoperative pathological staging (ypTN).

Time frame
Until sub-study completion, up to 38 months
4

Event-free survival (EFS)

EFS is defined as the time from the first dose of study intervention to documented Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or non-RECIST 1.1 disease progression that precludes radical surgery or requires non-protocol therapy during the neoadjuvant through surgery period, or to documented RECIST 1.1 or biopsy-confirmed non-RECIST 1.1 recurrence or progression of disease during the adjuvant period, or death due to any cause at any time.

Time frame
Until sub-study completion, up to 38 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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