Neoadjuvant pembrolizumab with a watch-and-wait strategy for patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) localized colon cancer: a randomized GERCOR G-109 PRODIGE 84 PREMICES phase II trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509322-22-00

Enrollment

Registered

2025-03-20

Start date

2025-11-26

Completion date

Unknown

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

localized colon cancer

Brief summary

The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization

Detailed description

The rate of strategy success at 24 months after randomization in the experimental arm, Safety (according to NCI CTCAE v 5.0) of experimental strategy, 3. OS at 6, 12 and 24 months in both study arms, EFS at 6, 12 and 24 months in both study arms, 30-day postoperative morbidity (the Clavien Dindo classification15 recommended) in patients operated in both treatment arms, Participant-reported symptoms, functioning and HRQoL (EORTC QLQ-C30; EORTC QLQ-CR29) at baseline, 3, 6, 12, and 24 months in both study arms, TRG (according to the Becker/Mandar system and the AJCC TNM system),, Endoscopic complete response (eCR)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGCAPECITABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization	—

Secondary

Measure	Time frame
The rate of strategy success at 24 months after randomization in the experimental arm, Safety (according to NCI CTCAE v 5.0) of experimental strategy, 3. OS at 6, 12 and 24 months in both study arms, EFS at 6, 12 and 24 months in both study arms, 30-day postoperative morbidity (the Clavien Dindo classification15 recommended) in patients operated in both treatment arms, Participant-reported symptoms, functioning and HRQoL (EORTC QLQ-C30; EORTC QLQ-CR29) at baseline, 3, 6, 12, and 24 months in both study arms, TRG (according to the Becker/Mandar system and the AJCC TNM system),, Endoscopic complete response (eCR)	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026