Table 2.
Active/ongoing trials for advanced/recurrent endometrial cancer.
| Trial | Study start date | Recruitment status | Treatment arms | Experimental maintenance therapy | Molecular assessment | Estimated enrollment | Primary endpoint(s) |
|---|---|---|---|---|---|---|---|
| First-line Phase 3 Immunotherapy | |||||||
|
MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15 (NCT05173987) |
February 3, 2022 | Recruiting | - Comparator: Carboplatin + paclitaxel - Experimental: Pembrolizumab |
Pembrolizumab | MMRd/MSI | N=350 (MMRd only) |
PFS, OS |
|
MK-3475-B21/KEYNOTE-B21/ENGOT-en11/GOG-3053 (NCT04634877) |
January 10, 2021 | Recruiting | - Comparator: Carboplatin + paclitaxel + placebo +/− EBRT +/− VBT1 - Experimental: Carboplatin + paclitaxel + pembrolizumab +/− EBRT +/− VBT1 |
Pembrolizumab | MMRd/MSI | N=990 | DFS, OS |
|
DUO-E (NCT04269200) |
May 21, 2020 | Recruiting | - Comparator Arm A: Carboplatin + paclitaxel + placebo - Experimental Arm B: Carboplatin + paclitaxel + durvalumab - Experimental Arm C: Carboplatin + paclitaxel + durvalumab + olaparib |
- Arm B: Durvalumab - Arm C: Durvalumab + olaparib |
MMRd/MSI | N=699 | PFS |
|
NRG-GY018 (NCT03914612) |
July 16, 2019 | Recruiting | - Comparator: Carboplatin + paclitaxel + placebo - Experimental: Carboplatin + paclitaxel + pembrolizumab |
Pembrolizumab | MMRd/MSI | N=590 (MMRp) N=220 (MMRd) |
PFS |
|
RUBY (NCT03981796) |
July 18, 2019 | Active, not recruiting | - Comparator: Carboplatin + paclitaxel + placebo - Experimental Part 1: Carboplatin + paclitaxel + dostarlimab - Experimental Part 2: Carboplatin + paclitaxel + dostarlimab + niraparib |
- Part 1: Dostarlimab - Part 2: Dostarlimab + niraparib |
MMRd/MSI | N=785 | PFS, OS |
|
ENGOT-EN9/LEAP-001 (NCT03884101) |
April 11, 2019 | Active, not recruiting | - Comparator: Carboplatin + paclitaxel - Experimental: Pembrolizumab + lenvatinib |
Pembrolizumab | MMRd/MSI | N=875 | PFS, OS |
|
AtTEnd (NCT03603184) |
October 2, 2018 | Active, not recruiting | - Comparator: Carboplatin + paclitaxel + placebo - Experimental: Carboplatin + paclitaxel + atezolizumab |
Atezolizumab | MMRd/MSI | N=550 | PFS, OS |
| First-line Phase 3 Non-Immunotherapy | |||||||
|
NRG-GY026 (NCT05256225) |
August 12, 2022 | Recruiting | - Comparator Arm I: Carboplatin + paclitaxel - Experimental Arm II: Carboplatin + paclitaxel + trastuzumab - Experimental Arm III: Carboplatin + paclitaxel + pertuzumab/trastuzumab |
- Arm II: Trastuzumab - Arm III: Pertuzumab/ trastuzumab |
HER2 | N=525 (HER2+ serous carcinoma or carcinosarcoma only) |
PFS, OS |
|
XPORT-EC (NCT05611931) |
November 1, 2022 | Recruiting | - Completed a single line of platinum-based therapy Comparator: Placebo Experimental: Selinexor |
Selinexor | TP53 wt | N=220 | PFS |
| Phase 2 | |||||||
|
DESTINY-PanTumor02 (NCT04482309) |
June 16, 2023 | Active, not recruiting | Trastuzumab deruxtecan | HER2 | N=268 | ORR | |
|
IMGN853- (NCT03832361) |
July 15, 2020 | Recruiting | Mirvetuximab soravtansine | FRα | N=50 | ORR | |
| 18-602 (NCT03835819) | January 2, 2020 | Recruiting | Mirvetuximab soravtansine + pembrolizumab | FRα and MMRp | N=35 | ORR, PFS | |
|
16-322 (NCT02912572) |
November 14, 2016 | Recruiting | - Avelumab - Avelumab + talazoparib |
MSI and/or POLE | N=105 | ORR, PFS | |
|
18-301 (NCT03675893) |
December 24, 2018 | Recruiting | Letrozole + abemaciclib | ER-positive | N=40 | ORR, PFS | |
|
INCMGA 0012-204 (NCT04463771) |
January 26, 2021 | Recruiting | - Retifanlimab - Retifanlimab + epacadostat - Retifanlimab + pemigatinib - Retifanlimab + INCAGN02385 + INCAGN2390 |
MSI, POLE, PD-L1, FGFR1/2/3 | N=300 | ORR | |
|
21-447 (NCT05156268) |
January 27, 2022 | Recruiting | Pembrolizumab + olaparib | p53 | N=25 | ORR | |
|
NRG-GY012 (NCT03660826) |
September 4, 2018 | Recruiting | - Arm I: Cediranib - Arm II: Olaparib - Arm III: Cediranib + olaparib - Arm IV: Capivasertib + olaparib - Arm V: Durvalumab + olaparib - Arm VI: Cediranib + durvalumab |
DNA homologous repair gene mutations | N=168 | PFS | |
|
NRG-GY025 (NCT05112601) |
February 7, 2022 | Recruiting | - Experimental Arm I: Ipilimumab + nivolumab - Active comparator Arm II: Nivolumab |
MMRd/MSI | N=12 | PFS | |
|
NU 18G07 (NCT04049227) |
August 12, 2019 | Recruiting | Abemaciclib + letrozole | MMR, PTEN, cyclin D1, p16, pRB | N=27 | Ki-67 expression | |
|
ZN-c3-004 (NCT04814108) |
June 1, 2021 | Recruiting | ZN-c3 | N=110 | ORR | ||
| Phase 1/2 | |||||||
|
MORAb-202 (NCT04300556) |
August 6, 2020 | Recruiting | Farletuzumab ecteribulin | FRα | N=55 | Dose escalation/ confirmation | |
|
DB-1303 (NCT05150691) |
January 31, 2022 | Recruiting | DB-1303 | HER2 | N=360 | Dose escalation/ confirmation | |
|
ZN-c3-001 (NCT04158336) |
November 1, 2019 | Recruiting | ZN-c3 | N=110 | Safety/ tolerability, ORR | ||
C: cycles; DFS: disease-free survival; EBRT: external-beam radiation therapy; ER: estrogen receptor; FRα: folate receptor alpha; HER2: human epidermal growth factor receptor 2; MMRd: mismatch repair–deficient; MMRp: mismatch repair–proficient; MSI: microsatellite instability; NCT: National Clinical Trial identification number; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; TP53 wt: TP53 wildtype; VBT: vaginal brachytherapy.
1
The standard of care radiotherapy regimen may include, at the discretion of the investigator, EBRT ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m2 IV on days 1 and 29 of EBRT, and/or VBT.