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Neo-Adjuvant Pembrolizumab as an alternative treatment for MMRd uterine cancer, a phase II efficacy study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516736-10-00
Acronym
PAM-UMCG-002
Enrollment
12
Registered
2024-09-05
Start date
2023-12-18
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Mismatch repair deficient endometrial cancer / uterine cancer

Brief summary

The main study endpoint is the fraction of patients that achieve a MPR. that the study is considered positive if neo-adjuvant pembrolizumab induces MPRs in at least 74% of patients.

Detailed description

The objective response rate of the tumor determined by radiologic assessment using MRI and RECIST1.1., Recurrence-free survival 2 years from disease diagnosis., The safety and tolerability of 9 cycles of neo-adjuvant pembrolizumab in the treatment of MMRd UC.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
The objective response rate of the tumor determined by radiologic assessment using MRI and RECIST1.1., Recurrence-free survival 2 years from disease diagnosis., The safety and tolerability of 9 cycles of neo-adjuvant pembrolizumab in the treatment of MMRd UC.

Primary

MeasureTime frame
The main study endpoint is the fraction of patients that achieve a MPR. that the study is considered positive if neo-adjuvant pembrolizumab induces MPRs in at least 74% of patients.

Countries

Netherlands

Outcome results

None listed

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