Table 1.
Active (i.e. ‘Recruiting’ and ‘Active, not recruiting’ in ClinicalTrials.gov) phase III clinical trials of immune checkpoint inhibitors combined with (chemo)radiotherapy
| Primary lesion | Study title | Radiotherapy | Immune checkpoint inhibitor | Design | NCT number |
|---|---|---|---|---|---|
| Anti-PD-1/PD-L1 antibody | |||||
| Head and neck | Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) | EBRT (60 Gy/30 fr. or 66 Gy/33 fr. or 70 Gy/35 fr.) | Pembrolizumab | Experimental: Pembrolizumab > surgery > Pembrolizumab + CRT Comparator: Surgery > CRT | NCT03765918 |
| Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412) | EBRT (70 Gy/35 fr.) | Pembrolizumab | Experimental: Pembrolizumab > CRT + Pembrolizumab > Pembrolizumab Comparator: Placebo > CRT + Placebo > Placebo | NCT03040999 | |
| Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer | IMRT (70 Gy/35 fr.) | Nivolumab | Experimental (Arm A): CRT > Nivolumab Comparator (Arm B): CRT Experimental (Arm C): Nivolumab |
NCT03811015 | |
| Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally advanced Nasopharyngeal Carcinoma | IMRT (70 Gy in 6–7 weeks) | Sintilimab | Experimental: chemotherapy + Sintilimab > CRT + Sintilimab Comparator: Chemotherapy > CRT | NCT03700476 | |
| Programmed Death-1 (PD-1) Antibody Combined With IMRT in Recurrent Nasopharyngeal Carcinoma Patients | IMRT (60–66 Gy/30–33 fr.) | Toripalimab | Experimental: RT + toripalimab Comparator: RT alone | NCT03907826 | |
| Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma | IMRT: (60–64 Gy/27 fr.) | Toripalimab | Experimental: CRT + toripalimab Comparator: CRT | NCT04453813 | |
| Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin | IMRT | Durvalumab | Experimental: IMRT + Durvalumab Comparator: IMRT + cetuximab | NCT03258554 | |
| Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma | IMRT | Camrelizumab | Experimental: Camrelizumab + CRT Comparator: CRT | NCT04453826 | |
| Lung | PD-1 Inhibitors and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer | EBRT (at least 18 Gy/3 fr.) | Pembrolizumab | Experimental: Pembrolizumab + CRT Comparator: Pembrolizumab + chemotherapy | NCT03774732 |
| Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Medically Inoperable Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867) | SBRT (45–54 Gy/3–5 fr.) | Pembrolizumab | Experimental: SBRT + Pembrolizumab Comparator: SBRT + placebo | NCT03924869 | |
| Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | EBRT (60 Gy/30 fr.) | Pembrolizumab | Experimental: Pembrolizumab + concurrent CRT > Pembrolizumab + placebo Experimental: Pembrolizumab + concurrent CRT > Pembrolizumab + olaparib Comparator: CRT > durvalumab | NCT04380636 | |
| Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer | SBRT | Pembrolizumab | Experimental: SBRT + Pembrolizumab Comparator: Pembrolizumab alone | NCT03867175 | |
| Durvalumab vs. Placebo Following Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer Patients (PACIFIC-4) | SBRT | Durvalumab | Experimental: SBRT > Durvalumab Comparator: SBRT > Placebo | NCT03833154 | |
| Esophagus | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) | EBRT (50 Gy/25 fr. or 60 Gy/30 fr.) | Pembrolizumab | Experimental: Pembrolizumab > Pembrolizumab + CRT Comparator: Placebo > Placebo + CRT | NCT04210115 |
| Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer | NS | Camrelizumab | Experimental: Camrelizumab + Paclitaxel + Cisplatin + radiotherapy Comparator: Placebo + Paclitaxel + Cisplatin + radiotherapy | NCT04426955 | |
| Liver | Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01) | SBRT (30–54 Gy/3–6 fr.) | Sintilimab | Experimental: SBRT > Sintilimab Comparator: SBRT | NCT04167293 |
| Uterine cervix | Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA) | EBRT + brachytherapy | Durvalumab | Experimental: durvalumab + CRT > durvalumab Comparator: placebo + CRT | NCT03830866 |
| Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11) | EBRT (45–50 Gy/23–28 fr.) + brachytherapy (25–30 Gy/4–6 fr.) | Pembrolizumab | Experimental: Pembrolizumab + CRT Experimental: Placebo + CRT | NCT04221945 | |
| Intestine | PD1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer | EBRT (50 Gy/25 fr.) | Sintilimab | Experimental: Sintilimab > surgery or watch and wait > Sintilimab ± chemotherapy Experimental cohort B (arm-1): Sintilimab + CRT > surgery or watch and wait > chemotherapy Comparator cohort B (arm-2): CRT > surgery or watch and wait > chemotherapy | NCT04304209 |
| Skin | Pembrolizumab Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630) | NS | Pembrolizumab | Experimental: surgery > radiotherapy > Pembrolizumab Comparator: surgery > radiotherapy | NCT03833167 |
| Lymphoma | A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL) | IMRT (54–56 Gy in 25–26 weeks) | Toripalimab | Experimental: toripalimab + chemotherapy > toripalimab + radiotherapy > toripalimab Comparator: chemotherapy > radiotherapy | NCT04365036 |
| Anti-PD-1/PD-L1 antibody + anti-CTLA-4 antibody | |||||
| Brain | Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma | NS | Nivolumab and Ipilimumab | Experimental: RT + Nivolumab + Ipilimumab Comparator: RT + Temozolomide > Temozolomide |
NCT04396860 |
| Head and neck | Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs. Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy | EBRT (56–66 Gy) | Nivolumab and Ipilimumab | Experimental: Nivolumab > surgery > RT or CRT > Nivolumab (arm Ia) or Nivolumab + Ipilimumab (arm Ib) Comparator: Surgery > RT or CRT |
NCT03700905 |
| Lung | Phase III Trial of (Local Consolidation Therapy; LCT) After Nivolumab and Ipilimumab | NS | Nivolumab and Ipilimumab | Experimental: Arm A (ipilimumab, nivolumab): (INDUCTION) Nivolumab + Ipilimumab > Nivolumab + Ipilimumab Experimental: Arm B (ipilimumab, nivolumab, LCT): (INDUCTION) Nivolumab + Ipilimumab > LCT (surgery and/or RT) > Nivolumab + Ipilimumab |
NCT03391869 |
| Esophagus | Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery | NS | Nivolumab and Ipilimumab | Experimental: Arm A: CRT Experimental: Arm B: CRT + Nivolumab Experimental: Arm C: Nivolumab Experimental: Arm D: Nivolumab + Ipilimumab |
NCT03604991 |
EBRT, externalbeam radiotherapy; fr., fractions; CRT, chemoradiotherapy; IMRT, intensity-modulated radiotherapy; RT, radiotherapy; SBRT, stereotactic body radiotherapy; LCT, local consolidation therapy.