Table IV.

Current clinical trials designed to evaluate the effect of combination ionizing radiation and immune checkpoint blockade.

Institution/Study ID	Tumor site/stage	Primary study aim	RT	ICB	Inclusion criteria
University of Pittsburgh/NCT01935921	PULA HNSCC	DLTs	2Gy × 35	CTLA-4 mAb	Stage III/IVB excluding T1N1 histologically confirmed SCC or undifferentiated carcinoma
Sanford Health/NCT02586207	PULA HNSCC	DLTs	2Gy × 35	PD-1 mAb	Stage III/IVB HNSCC histologically confirmed, measurable disease, no prior RT
RTOG (multicenter)/NCT02764593	PULA HNSCC	DLTs	2Gy × 35	PD-1 mAb	Stage III/IVB HNSCC histologically confirmed, measurable disease, no prior RT
University of Cincinnati/NCT02759575	PULA HNSCC	DLTs	2Gy × 35	PD-1 mAb	Stage III or IV SCC of the larynx, measurable disease, no prior RT
University of Cincinnati/NCT02641093	Adjuvant for resected HNSCC	DLTs, DFS	2Gy × 30	PD-1	Any T stage with at least N2 disease, T4 disease any N stage, T3 oral cavity any N stage, clinical evidence of extra-capsular extension on scans, willing to undergo definitive resection with neck dissection
Groupe Oncologie Radiotherapie Tete et Cou/NCT02707588	Locally-advanced HNSCC	LRC of ICB+IMRT vs cetuximab+IMRT	2.12Gy × 33	PD-1	Histologically confirmed previously untreated locally advanced HNSCC
UNC Lineberger Cancer Center/NCT02609503	Locally-advanced HNSCC	PFS	2Gy × 35	PD-1	Histologically confirmed stage III–IV (non-metastatic) HNSCC, ineligible for high-dose cisplatin therapy, no prior curative attempts
University of Maryland/NCT02289209	Locoregional inoperable recurrence or second primary HNSCC	PFS	1.2Gy BID for 5 days a week for 5 weeks	PD-1	Histologically confirmed locoregional recurrence or second primary HNSCC which is unresectable or the patient is unwilling to undergo resection, received only prior RT with curative intent, at least 1 measurable area of disease within previously radiated field
University of California, San Diego/NCT02843165	Metastatic disease including HNSCC	ORR of ICB alone vs ICB+SBRT	9.5Gy × 3	PD-1, PD-L1, CTLA-4 mAb	At least 1 lesion treatable by SBRT, histologic confirmation of malignancy (primary or metastatic), no prior radiotherapy to treatment site
Sidney Kimmel Cancer Center at Thomas Jefferson University/NCT02318771	Recurrent/metastatic HNSCC, RCC, Mel, NSCLC	Immune correlates	8Gy × 1, 4Gy × 5	PD-1 mAb	Histologically-confirmed recurrent/metastatic HNSCC, RCC, melanoma, or lung CA with at least 1 measurable lesion in addition to the index lesion
Memorial Sloan Kettering/NCT02684253	Metastatic HNSCC	ORR of ICB alone vs ICB+SBRT	9Gy × 3	PD-1	Histologically confirmed metastatic HNSCC, at least 2 lesions