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Table 3 Clinical trials for checkpoint inhibitors in combination with standard care of treatment

From: T cell exhaustion: from pathophysiological basics to tumor immunotherapy

Agent (inhibited check-point) Setting Phase Treatment Tumor response OS (PFS) in months Toxicity irAE grade ≥3 Ref.
Ipilimumab (CTLA-4) Advanced melanoma III Ipilimumab or Ipilimumab + glycoprotein 100 or glycoprotein 100 only NM 10 vs 10.1 vs 6.4 (2.76 vs 2.86 vs 2.76) Diarrhea, nausea, constipation, vomiting, abdominal pain [171]
Advanced melanoma Retrospective Ipilimumab or maintenance + median 30 Gy NM 9 vs 39 NM [172]
Advanced melanoma Retrospective Ipilimumab vs Ipilimumab + radiotherapy NM 10.2 vs 19.6 Rash, colitis, GI, fatigue [173]
Advanced melanoma I Ipilimumab plus radiotherapy NM 10.7 (3.8) Anemia, diarrhea, colitis [220]
Metastatic melanoma II Ipilimumab + sargramostim vs Ipilimumab alone NM 17.5 vs 12.7 (3.1 vs 3.1) Diarrhea, rash, colitis, elevated liver enzymes [174]
Metastatic NSCLC I Ipilimumab + Paclitaxel vs Ipilimumab + Carboplatin NM NM Adrenal insuffiency, enterocolitis [221]
Advanced, bone metastasis, castration-resistant prostate cancer III Ipilimumab or placebo after 8 GY NM 11.2 vs 10.2 (4.0 vs 3.1; at 6 MO 30.7% vs 18.1%) Diarrhea, colitis [222]
Tremel-imumap (CTLA-4) Prostate cancer (PSA-recurrent) I Tremeli-mumab + Bicalutamide NM NM Colitis [208]
Advanced breast cancer I Tremeli-mumab + Exemestane SD 42% NM Diarrhea, rash [207]
Metastatic pancreatic cancer I Tremeli-mumab + Gemcitabine PR 10.5% 7.4 Asthenia, nausea, diarrhea [223]
Advanced melanoma (or solid tumors) I Tremeli-mumab + PF-3512676 (CPG 7909) = Toll like receptor 9 inhibitor NM 19 Diarrhea, hypophy-sitis, colitis, nausea, vomiting, pruritus, rash, neutropenia, rectal Bleeding [224]
Advanced melanoma II Trimilimumab + high dose INFalpha (HDI) ORR 24% CR 11% PR 14% SD 38% 21 (6.4) Diarrhea, colitis, elevated liver enzymes, rash, fatigue, anxiety/depression [184]
Metastatic renal cell carcinoma I Tremeli-mumab + sunitinib PR 42.8%; SD 9.5% 2.8–18.2MO Fatigue, mucositis, dypnea [225]
Nivolumab (PD-1) Resected advanced melanoma II Adjuvant Nivolumab + multi-peptide vaccine (gp100, MART-1 & NY-ESO-1 with Montanide ISA 51 VG) NM At 1a 87%
At 2a 82%
Colitis, enteritis, rash, hypokalemia [226]
Pidilizumab (PD-1) Relapsed follicular lymphoma II Pidilizumab + Rituximab ORR 66% CR 52% PR 14% NM No grade 3 or higher irAE [199]
DLBCL II Pidilizumab after autologous hematopoietic stem- cell transplan-tation ORR 51% CR 34% PR 17% SD 37% PD 11% At 16 MO 0.85% (at 16 MO 0,72%) Thrombo-cytopenia, anemia, pyrexia, renal failure, [200]
Atezoli-zumab (PD-L1) Microsatellite stable metastatic colorectal cancer Ib Combination of cobimetinib and ateolizumab ORR 17% and 20% in KRAS-mutant tumors At 6 MO 72% NM [203]
  1. Abbreviations: CR complete response, irAE immune related adverse effects, MO months, NM not mentioned, NSCLC non small cell lung cancer, ORR overall response rate, OS overall survival, PD progressive disease, PFS progression free survival, PR partial response, SD stable disease