4
Indication details
- Combined Agent(s)
- Carboplatin and paclitaxel
- Control Arm
- Carboplatin, paclitaxel, and placebo
- Therapeutic Indication
- Pembrolizumab with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. (Cohort data with pMMR)
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Endometrial Cancer
- Tumour Stage
- Recurrent or advanced
- Trial Name
- KEYNOTE-868/NRG-GY018
- NCT Number
- NCT03914612
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval June 2024
- Comment
- Approval for cohort data with pMMR
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 8.7 months
- PFS Gain
- 4.4 months
- PFS HR
- 0.54 (0.41-0.71)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- 7 patients (2.4%) available at 24 m
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 454
- Scorecard version
- 1
- Issue date
- 24.07.2024