Table 1.
Published or ongoing trials of immunotherapy in EC:
| Mechanism of action | NCI identifie | Agents | Phase | Setting/cancer type | Patient number | Subtype contribution | Outcomes | Status |
|---|---|---|---|---|---|---|---|---|
|
anti-PD-1 antibody |
NCT01876511 | Pembrolizumab | II | Advanced MMR-deficient Cancers including EC | Total:86, EC:15 | all MMR-d | ORR, DCR, PR, SD, PD | published |
| NCT02054806 | Pembrolizumab | Ib | PD-L1 positive Advanced EC | 24 | POLE:1, MSI-high:1, MSS:17, Not evaluable:5 | ORR, median PFS, median OS, PR, SD, PD | published | |
| NCT02628067 | Pembrolizumab | II | Noncolorectal MMR-d cancers including EC | Total:233, EC:49 | all MMR-d | CR, PR, ORR, median PFS, median OS, median DOR | published | |
| NCT02465060 | Nivolumab | II | Noncolorectal MMR-d cancers including EC | Total:42, EC:13 | all MMR-d | ORR, CR, PR, SD, PD, median PFS | published | |
|
Abti-PD-1 antibody+ Antiangiogenic therapy |
NCT03015129 |
Pembrolizumab+ Lenvatinib |
II | rEC | 108 | MSI:11,MSS:94 | ORR, PFS, OS, DOR | published |
| anti-PD-L1 antibody | NCT01375842 | Atezolizumab | Ia | rEC | 15 | MSI-H:1, MSS:7, unknown for MMR status:7 | ORR, PFS,OS | published |
| NCT02912572 | Avelumab | II | rEC | 33 | MSS:16, MSI:17 | OR, PFS6 | published | |
| ACTRN12617000106336 | Durvalumab | II | advanced EC | 71 | MSI:36, MSS:35 | OTR, PFS, OS | published | |
|
anti-PD-L1 antibody+ anti-CTLA-4 |
NCT03015129 | Durvalumab and Tremelimumab versus Durvalumab Monotherapy | II | rEC and Endometrial Carcinosarcoma | Total:56, EC:41 | MSI:5, MSS:48, unknown:3 | ORR, median DOR, PFS, PFS rate at 24 wks | published |
| tumor antigen loaded DC cancer vaccine | EudraCT 2009-016868-37 |
WT1mRNA-electroporated mature DCs (DCm-WT1- RNA) |
I/II | Uterine Tumor | Total:6, serous EC:3 | NA |
PFS, OS, Oncologic outcome (CT Scan, CA125), Immune Response (WT1-specific T-cells, NK cells) |
published |
|
peptide cancer vaccine+ anti-tumor cytokine |
NCT01580696 |
E39 peptide waccine+ GM-CSF |
I/IIa | Ovarian and EC | Total:51, EC:9 | NA | DFS | published |
| Chimeric peptide cancer vaccine | BB-IND-9803 | B-cell epitopes of HER2-Th (MVF) epitope chimeric peptide vaccine | I | Metastatic and/or Recurrent Solid Tumors including EC | Total:24, EC:1 | NA | antibody response, PR, SD | published |
|
nucleic acid-based cancer vaccine+ anti-PD-1 antibody |
NCT03313778 |
mRNA-4157 vaccine+ Pembrolizumab |
I | Resectable/Unresectable Solid Tumors including EC | Total:33, EC:1 | MSI | PR, SD, PD, neoantigen-specific T cell response | published |
|
ACT+ hyperthermia+ anti-PD-1 antibody/ chemotherapy |
NCT03757858 |
Autologous Adoptive T cell Transfer+ Hyperthermia+ Pembrolizumab/ Chemotherapy |
I | Advanced Solid Tumors including EC | Total:33, EC:5 | NA |
ORR, DCR, Clinical Response (CR, PR, SD, PD) |
published |
| anti-PD-1 antibody | NCT02628067 | Pembrolizumab | II | Advanced Solid Tumors including EC | NA | NA | ORR | Recruiting |
| NCT02630823 | Pembrolizumab | I | Surgically Resectable EC | NA | NA | AEs | Active, not recruiting | |
| NCT02728830 | Pembrolizumab | I | Gynecologic Cancers including EC | NA | NA | Fold change in tumor Immune Infiltrates | Active, not recruiting | |
| NCT02899793 | Pembrolizumab | II | Advanced, Recurrent or Metastatic EC | NA | POLE,MSI | ORR,AEs | Recruiting | |
| NCT03241745 | Nivolumab | II | Metastatic or Recurrent Uterine Cancer | NA | all dMMR(EC) | PFS | Recruiting | |
| NCT03568539 | IBI308 | Ib | Advanced or Metastatic Solid Tumors including EC | NA | NA | Overall Response Rate,CR,PR | Active, not recruiting | |
|
anti-PD-1 antibody+ Surgery |
NCT03694834 |
Pembrolizumab+ Hysterectomy+ Surgical staging |
I | Early Stage, High Grade Obesity-driven EC | NA | NA | TIL | Suspended |
|
anti-PD-1 antibody+ Surgery+ Chemotherapy |
NCT03932409 |
Pembrolizumab+ Vaginal Cuff Brachytherapy+ Paclitaxel+ Carboplatin |
Ib | High Intermediate Risk EC | NA | NA | Proportion of patients completing three cycles | Not yet recruiting |
|
anti-PD-1 antibody+ Chemotherapy |
NCT02549209 |
Pembrolizumab+\Carboplatin+ Paclitaxel |
II |
Advanced, Recurrent or Metastatic EC |
NA | NA | ORR | Recruiting |
| NCT03276013 |
Pembrolizumab+ Doxorubicin |
II |
Advanced, Recurrent or Metastatic EC |
NA | NA | PFS | Active, not recruiting | |
| NCT03981796 |
Dostarlimab+ Carboplatin- Paclitaxel |
III |
Advanced, Recurrent or Metastatic EC |
NA |
will do MMR evaluation |
PFS | Recruiting | |
| NCT03914612 |
Pembrolizumab+ Paclitaxel+ Carboplatin |
III |
Stage III/IV or Recurrent EC |
NA |
will do MMR evaluation |
PFS | Recruiting | |
| anti-PD-1 antibody+Radiotherapy | NCT04214067 |
Pembrolizumab+ Radiation therapy |
III | High Intermediate Risk Endometrioid EC | NA | all dMMR |
3 year recurrence -free survival |
Not yet recruiting |
| NCT03955978 |
Dostarlimab+ Standard of Care Definitive Radiation |
I | Inoperable EC | NA | NA | Safety and tolerability | Recruiting | |
| anti-PD-1 antibody+PARP inhibitor | NCT03016338 |
Dostarlimab+ Niraparib |
II | Advanced,Recurrent or Metastatic EC | NA | NA | Clinical benefit rate | Recruiting |
| NCT03572478 |
Nivolumab+ Rucaparib |
Ib/IIa | Advanced or Recurrent EC and Metastatic Castrate-Resistant Prostate Cancer | NA | NA | DLT rate | Recruiting | |
|
anti-PD-1 antibody+ Antiangiogenic therapy |
NCT04197219 |
Pembrolizumab+ Axitinib |
II | Advanced, Recurrent or Metastatic EC | NA | all dMMR |
ORR,CR, PR |
Not yet recruiting |
| NCT02501096 |
Pembrolizumab+ Lenvatinib |
Ib/II | metastatic Solid Tumors including EC | NA | NA | MTD,ORR,DLT | Active, not recruiting | |
| NCT03367741 |
Nivolumab+ Cabozantinib |
II | Advanced, Recurrent or Metastatic EC | NA | NA | PFS | Suspended | |
| NCT03517449 |
Pembrolizumab+ Lenvatinib |
III | Advanced, Recurrent or Metastatic EC | NA | will do MMR evaluation | PFS,OS | Active, not recruiting | |
| NCT03884101 |
Pembrolizumab+ Lenvatinib |
III | Advanced, Recurrent or Metastatic EC | NA | will do MMR evaluation | PFS,OS | Recruiting | |
| NCT04157491 |
anti-PD-1 antibody+ Anlotinib |
II | Advanced, Recurrent or Metastatic EC | NA | NA |
ORR,CR, PR |
Recruiting | |
| anti-PD-1 antibody+IDO inhibitor | NCT02178722 |
Pembrolizumab+ Epacadostat (INCB024360) |
I/II | Cancers including EC | NA | NA | TEAEs, ORR | Active, not recruiting |
| NCT04106414 |
Nivolumab+ BMS-986205 |
II | Recurrent or Persistent EC or Endometrial Carcinosarcoma | NA | will do MMR evaluation | Best overall response rate | Recruiting | |
|
anti-PD-1 antibody+ anti-CTLA-4 antibody |
NCT02982486 |
Nivolumab+ Ipilimumab |
II | Nonresectable or Metastatic EC and Sarcoma | NA | all dMMR | CR,PR | Not yet recruiting |
|
anti-PD-1 antibody+ 4-1BB antibody |
NCT03917381 | GEN1046 | I/II | Malignant Solid Tumors including EC | NA | NA |
DLT,AEs, Safety laboratory parameters |
Recruiting |
|
anti-PD-1 antibody+ CFTR inhibitor |
NCT04014530 |
Pembrolizumab+ Ataluren |
I/II | Metastatic EC and Colorectal Adenocarcinoma | NA | all dMMR(EC) | ORR | Recruiting |
|
anti-PD-1 antibody+ Dual Adenosine Receptor (A2aR/A2bR) Antagonist |
NCT03629756 |
Zimberelimab (AB122)+ AB928 |
I | Advanced Solid Tumors including EC | NA | NA | DLTs,AEs | Recruiting |
|
anti-PD-1 antibody+ FRα ADC |
NCT03835819 |
Pembrolizumab+ Mirvetuximab Soravtansine (IMGN853) |
II | Advanced, Recurrent or Metastatic EC | NA | all MSS | ORR, PFS | Recruiting |
|
anti-PD-1 antibody+ Hormone |
NCT04046185 |
Toripalimab+ Progesterone |
I |
Early EC (preserve fertility) |
NA | NA |
Pathologic complete /patrial remission rate |
Not yet recruiting |
| anti-PD-1 antibody+IAP | NCT04122625 |
Nivolumab+ Mimetic Debio 1143 |
Ib/II | Solid Tumors including EC, progressed during/immediately after anti-PD-1/PD-L1 treatment | NA | known MMR status | ORR | Recruiting |
|
anti-PD-1 antibody+ Immune Modulatory Cocktail+ Radiotherapy+ Food supplement |
NCT03192059 |
Pembrolizumab+ Immune Modulatory Cocktail (Vitamin D+ Lansoprazole Teva+ Cyclophosphamide+Aspirine,) +Radiotherapy +Curcumin |
II | Refractory or Recurrent EC, CC, Uterine sarcoma | NA | NA | ORR | Recruiting |
|
anti-PD-1 antibody+ multi-targeted RTK inhibitor |
NCT03827837 |
Camrelizumab+ Famitinib |
II | Advanced RCC/UC/CC/EC and Recurrent OC | NA | NA | Overall response rate | Recruiting |
|
anti-PD-1 antibody+ PVRIG antibody |
NCT03667716 |
COM701 monotherapy or COM701+ Nivolumab |
Ia/b | Advanced or Metastatic Solid Tumors including EC | NA | NA | AEs ,DLTs,MTD, RDFE | Recruiting |
| anti-PD-L1 antibody | NCT02725489 | Durvalumab+Vigil | II | Advanced Women's Cancers including EC | NA | NA | AEs | Active, not recruiting |
| NCT03212404 | Cosibelimab | I |
Advanced or Metastatic Solid Tumors including EC |
NA | NA | DLT,AEs,ORR | Recruiting | |
|
anti-PD-L1 antibody+ Chemotherapy |
NCT02914470 |
Atezolizumab+ Carbplatin+ Cyclophophamide |
Ib | Advanced Gynaecologic Cancer including EC,BC | NA | NA | Toxicity, Incidence of toxicity,AEs | Active, not recruiting |
| NCT03503786 |
Avelumab+ Carboplatin+ Paclitaxel |
II |
Advanced, Recurrent or Metastatic EC |
NA | NA | PFS | Not yet recruiting | |
| NCT03603184 |
Atezolizumab+ Paclitaxel+ Carboplatin |
III |
Advanced, Recurrent or Metastatic EC |
NA | Will do MMR evaluation | OS,PFS | Recruiting | |
|
anti-PD-L1 antibody+ Antiangiogenic therapy |
NCT03170960 |
Atezolizumab+ Cabozantinib |
Ib | Advanced or Metastatic Solid Tumors including EC | NA | NA | MTD/RD,ORR | Recruiting |
| NCT03526432 | Atezolizumab+ Bevacizumab | II | Advanced, Recurrent or Metastatic EC | NA | will do MMR evaluation | Number of patients who experience CR or PR | Recruiting | |
| anti-PD-L1 antibody+PARP inhibitor | NCT02912572 |
Avelumab/ Avelumab+ Talazoparib |
II | Advanced, Recurrent or Metastatic EC | NA | POLE,MSI,MSS | PFS | Recruiting |
| NCT03101280 |
Atezolizumab+ Rucaparib |
Ib | Advanced Gynecologic Cancers inclunding EC, TNBC | NA | NA | AEs,DLTs,RP2D,Number of Dose Modifications due to AEs | Active, not recruiting | |
| NCT03951415 |
Durvalumab+ Olaparib |
II | Advanced, Recurrent or Metastatic EC | NA | NA | PFS | Recruiting | |
|
anti-PD-L1 antibody+ Chemotherapy+ PARP inhibitor |
NCT04269200 |
Durvalumab+ Carboplatin+ Paclitaxel+ Olaparib |
III | Advanced, Recurrent or Metastatic EC | NA | will do MMR evaluation | PFS | Not yet recruiting |
|
anti-PD-L1 antibody+ Antiangiogenic therapy+ PARP inhibitor |
NCT03694262 |
Atezolizumab+ Bevacizumab+ Rucaparib |
II | Advanced, Recurrent or Metastatic EC | NA | will do MMR evaluation | Overall Response Rate | Recruiting |
|
anti-PD-L1 antibody+ IDO inhibitor |
NCT02471846 |
Atezolizumab+ GDC-0919 |
Ib | Advanced or Metastatic Solid Tumors including EC | NA | NA | DLTs,AEs | Completed |
|
anti-PD-L1 antibody+ anti-CTLA-4 antibody |
NCT03015129 |
Durvalumab+ Tremelimumab |
II | Persistent or Recurrent EC and Endometrial Carcinosarcoma | NA | NA | Overall Response Rate | Recruiting |
|
anti-PD-L1 antibody+ anti-CTLA-4 antibody+ Radiotherapy |
NCT03277482 |
Durvalumab+ Tremelimumab+ Radiotherapy |
I | Recurrent Gynecologic Cancer including EC | NA | NA | MTD | Recruiting |
|
anti-PD-L1 antibody+ anti-5T4 antibody-superantigen fusion protein |
NCT03983954 |
Durvalumab+ Naptumomab |
Ib/II | Advanced or Metastatic Solid Tumors including EC | NA | NA | AEs,MTD,RP2D | Recruiting |
|
Dual Blockade of PD-1 and CTLA-4 |
NCT03517488 | XmAb20717 | I | Advanced Solid Tumors including EC | NA | all dMMR(EC) | AEs | Recruiting |
| anti-B7-H4 antibody | NCT03514121 | FPA150 | Ia/b | Advanced or Metastatic Solid Tumors including EC | NA | NA | MTD,RD,AEs | Active, not recruiting |
| anti-LAG-3 antibody | NCT03538028 | INCAGN02385 | I | Advanced or Metastatic Solid Tumors including EC | NA | all dMMR(EC) | TEAEs | Recruiting |
CR Complete Response, DCR Disease Control Rate, DOR Duration of Response, OR Objective Response, ORR Objective Response Rate, OS Overall Survival, OTR Objective Tumour Response, PD Progressive Disease, PFS Progression-Free Survival, PFS6 Progression-Free Survival at 6 months, PR Partial Response, rEC advanced or recurrent EC, SD Stable Disease, ADC Antibody-drug conjugates, AEs Adverse Events, BC Breast Cancer, CC Cervical Cancer, DLTs Dose-Limiting Toxicities, MTD Maximum Tolerated Dose, OC Ovarian Cancer, RCC Renal Cell Carcinoma, RD Recommended Dose, RDFE Recommended Dose for Expansion, RP2D Recommended Phase II Dose, TEAEs Treatment-Emergent Adverse Events, TIL Tumor Infiltrating Lymphocytes, TNBC Triple-Negative Breast Cancer, UC Urothelial Carcinoma.