Table 2.

Administered treatment schedule, clinical responses, adverse events, and subsequent treatments across cohort.

Patient	Cohort 1	Bacillus Calmette–Guérin (BCG) dose	Site(s) of BCG injection	Number of ipilimumab doses received	Response		Sites of progression	irAEs	Other AEs	Subsequent treatment
					Injected lesions	Noninjected sites
1	Group 1	0.16–0.64 × 106 cfu	Left axillaa	4			PD—required resection	PD	Abdominal wall, pelvic node	G1 pruritus	G1 fatigue, G1 left axillary discomfort	Nivolumab
2	Group 1	0.16–0.64 × 106 cfu	Right axillab	4	SD	PD	Bone, liver	0	G1 fatigue, G1 nausea	Nivolumab
3	Group 1	0.16–0.64 × 106 cfu	Left axillary nodulea	2	SD	PD	Pulmonary, pleura, bone, and hepatic	0	G1 fatigue	Dabrafenib and trametinib
4	Group 2	0.80–3.20 × 106 cfu	Right upper thigha	1	NE	NE	NE	G1 diarrhea, G3 pruritus, G3 rash, G3 hepatitis	G1 nausea, G2 fatigue	Dabrafenib and trametinib
5	Group 2	0.80–3.20 × 106 cfu	Right anterior chest wall, right shouldera	3	PD	PD	Cutaneous lesions	G1 pruritus, G1 rash, G2 diarrhea, G3 small bowel ileus, G4 colitis	G1 fatigue	DTIC

irAEs, immune-related adverse events; AEs, adverse events, PD, progressive disease; SD, stable disease; NE, not evaluated; Gn, grade n.

^aSubcutaneous.

^bLymph node.