Table 3.
Ongoing clinical research on PD-1/PD-L1 in cervical cancer.
| Clinical trial code | Study | Study population (n) | Phase | Treatment arm(s) | Primary outcome measures | Secondary outcome measures |
|---|---|---|---|---|---|---|
| NCT02257528 | Nivolumab in Treating Patients with Persistent, Recurrent, or Metastatic Cervical Cancer (NRG-GYO-02) | Recurrent or metastatic cervical cancer (25) | II | Nivolumab | ORR1 [5 y]; AE2 [100 d] | PFS3 [5 y], OS4 [5 y] |
| NCT03298893 | Nivolumab in Association with Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months (NiCOL) | Locally advanced cervical cancer (21) | III | Nivolumab | DLT5 [11 w] | ORR1 [2 m], PFS3 [2 y], DFS6 [2 y], SAE7 [100 d], AE2 [100 d], etc. |
| NCT03257267 | Study of REGN2810 in Adults with Cervical Cancer (GOG 3016/ENGOT-cx9) (EMPOWER-Cervical) | Recurrent or metastatic platinum-refractory cervical cancer (436) | III | Cemiplimab (REGN2810) | OS4 [32 m] | PFS3 [32 m], ORR1 [32 m], DOR8 [32 m], Quality of life (QOL) [100 w] |
| NCT03104699 | Phase 1/2 Study of AGEN2034 in Advanced Tumors and Cervical Cancer | Advanced cervical cancer (75) | I–II | AGEN2034 | DLTs5 [3 w], MTD9 [1 y], BOR10 [1 y] | Cmax11 [1 y], AUC12 [1 y], PFS3 [1 y], DOR8 [1 y], OS4 [1 y] |
| NCT03518606 | Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients with Advanced Solid Tumors (MOVIE) | Advanced solid tumors (150) including cervical cancer | I–II | Durvalumab+Tremelimumab+metronomic Vinorelbine | Phase I: MTD9 and RP2D13 [9 m] Phase II: CBR14 [24 m] | None |
| NCT03556839 | Platinum Chemotherapy Plus Paclitaxel with Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix | Carcinoma of the cervix, stage IVB (404) | III | Atezolizumab | OS4 [48 m] | PFS3 [48 m], ORR1 [48 m], DOR8 [48 m], AE2 [48 m], etc. |
| NCT01975831 | A Phase 1 Study to Evaluate MEDI4736 in Combination with Tremelimumab | Solid tumors (106) including cervical cancer | I | MEDI4736 (Durvalumab)+Trem elimumab | AE2 [1 y] | AUC12, Cmax11 [15 m], PFS3 [15 m], OS4 [15 m], etc. |
| NCT02914470 | Pilot Study of Durvalumab and Vigil in Advanced Women’s Cancers (PROLOG) | Solid tumors (12) including cervical cancer | I | Durvalumab and Vigil | Toxicity [30 d] | ORR1 [120 m] |
| NCT02725489 | Pilot Study of Durvalumab and Vigil in Advanced Women’s Cancers | Solid tumors (15) including cervical cancer | II | Vigil+durvalumab | AEs2 [90 d] | ORR1 [12 m], Disease status [12 m], IFNγ-ELISPOT conversion rate [12 w] |
| NCT02921269 | Atezolizumab and Bevacizumab in Treating Patients with Recurrent, Persistent, or Metastatic Cervical Cancer | Recurrent, persistent, or metastatic cervical cancer (22) | II | Atezolizumab+Bevac izumab | ORR1 [2 y] | PFS3 [2 y], OS4 [2 y] AE2 [30 d], PD-L1, etc. |
| NCT03635567 | Efficacy and Safety Study of First-line Treatment with Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women with Persistent, Recurrent, or Metastati Cervical Cancer (MK-3475-826/KEYNOTE-826) | Cervical cancer (600) c | I–II | Pembrolizumab | PFS3 [2y] OS4 [2 y] | ORR1 [2 y], DOR8 [2 y], etc. |
| NCT03144466 | A Study of Pembrolizumab And Platinum with Radiotherapy in Cervix Cancer (PAPAYA) | Cervical cancer (26) | I | Pembrolizum | MTD9 [2 y] ab Efficacy [2 y] | OS4 [2 y], PFS3 [2 y], etc. |
| NCT03255252 | Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX) | Cervical cancer (100) | II | Cisplatin | Expression of CD8+CD39+PD1+ | Effect on 1-year DFS6 of other putative biomarkers (CD73, CD39, PD1 and Tim3) |
| NCT03559803 | A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer(GHR002) | Cervical cancer(50) | Not appli cable | Cisplatin | PD-L1 [3w, 2 m] | PD1+CD4+T [3w, 2 m], PD1+CD8+T [3w, 2 m], TCR[3w, 2 m] |
1ORR, objective response rate; 2AE, adverse event; 3PFS, progression-free survival; 4OS, overall survival rate; 5DLT, dose limiting toxicity; 6DFS, disease-free survival; 7SAE, serious adverse event; 8DOR, duration of response; 9MTD, maximum tolerated dose; 10BOR, best overall response; 11Cmax, maximum plasma concentration; 12AUC, area under curve; 13RP2D, phase II recommended dose; 14CBR, clinical benefit response.