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Monoclonal Antibodies

FLOT plus Avelumab (FLOT-A) for Stomach Cancer (ICONIC Trial)

Phase 2
Waitlist Available
Led By Marco Gerlinger, MD, FRCP
Research Sponsored by Royal Marsden NHS Foundation Trust
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

A single centre phase II trial of peri-operative chemo-immunotherapy in operable gastro-oesophageal adenocarcinoma (GOA). This trial is designed to evaluate the safety and efficacy of administering Avelumab, an anti-PD-L1 monoclonal antibody, with cytotoxic FLOT chemotherapy for patients with operable GOA treated according to a peri-operative protocol. This trial is in 2 stages: the first stage will establish the safe and tolerated maximum administered dose (MAD) of Avelumab in combination with FLOT and the second stage will assess the efficacy of this combination therapy in achieving pathological complete response (pCR) and peri-operative safety.

Eligible Conditions
  • Stomach Cancer
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 years of study opening
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 years of study opening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathological complete response rate of combination FLOT-A
Secondary study objectives
Median overall survival by Kaplan Meir method
Median progression free survival by Kaplan Meir method
Number of participants with grade 3 or 4 treatment-related adverse events as assessed by CTCAE v4.0
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FLOT plus Avelumab (FLOT-A)Experimental Treatment1 Intervention
Avelumab 10mg/kg (or Maximum Administered Dose established in safety run-in) iv infusion over 1 hour. Followed by FLOT: Oxaliplatin 85mg/m2 iv infusion day 1 over 2 hours, Folinic acid 200mg/m2 iv infusion day 1 over 2 hours, Docetaxel 50mg/m2 iv day 1 over 1 hour, Fluorouracil 2600mg/m2 over 24 hours iv

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Who is running the clinical trial?

Royal Marsden NHS Foundation TrustLead Sponsor
323 Previous Clinical Trials
10,150,702 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
443 Previous Clinical Trials
114,526 Total Patients Enrolled
Marco Gerlinger, MD, FRCPPrincipal InvestigatorThe Royal Marsden NHSFT
~5 spots leftby Oct 2025
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