Table 1.

Ongoing neoadjuvant ICI trials prior to surgery across different tumor types

ClinicalTrials.gov identifierStudy namePhase of the clinical trialTrial statusEstimated enrollment
NSCLC
NCT03237377Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung CancerPhase IIRecruiting32
NCT03197467Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer (NEOMUN)Phase IIRecruiting30
NCT03081689Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer PatientsPhase IIActive, not recruiting46
NCT02994576Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer (PRINCEPS)Phase IIRecruiting60
NCT02818920Neoadjuvant Pembrolizumab (TOP 1501)Phase IIRecruiting32
NCT02259621Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC (NA_00092076)Phase IIRecruiting30
NCT02927301A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)Phase IIRecruiting180
NCT02572843Anti-PD-L1 in Stage IIIA(N2) Non-small Cell Lung Cancer (NSCLC)Phase IIRecruiting68
NCT02716038Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLCPhase IIRecruiting30
NCT03158129Study Of Induction Checkpoint Blockade For Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable For Surgical ResectionPhase IIRecruiting66
NCT03732664Neoadjuvant Nivolumab in Resectable Non-Small-Cell Lung CancerPhase IRecruiting40
Head and neck cancer
NCT03700905Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy (IMSTAR-HN)Phase IIIRecruiting276
NCT02296684Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell CarcinomaPhase IIRecruiting66
NCT03021993Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity CancerPhase IIRecruiting19
NCT03247712Neoadjuvant Immunoradiotherapy in Head & Neck CancerPhase I/IIRecruiting18
NCT03003637ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced or Recurrent Head and Neck Carcinoma (IMCISION)Phase I/IIRecruiting32
NCT03129061Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)Phase IRecruiting24
NCT02812524Ipilimumab for Head and Neck Cancer PatientsPhase IRecruiting18
Melanoma
NCT03639948Neoadjuvant Combination Targeted and Immunotherapy for Patients With High-Risk Stage III Melanoma (NeoACTIVATE)Phase IIRecruiting30
NCT02519322Nivolumab With or Without Ipilimumab or Relatlimab Before Surgery in Treating Patients With Stage IIIB-IV Melanoma That Can Be Removed by SurgeryPhase IIRecruiting53
NCT02977052Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo), PRADO extension cohortPhase IIRecruiting110
NCT02858921Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma (NeoTrio)Phase IIRecruiting60
NCT02306850Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma (NeoPembroMel)Phase IIRecruiting15
Urologic malignancies
NCT03055013Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing NephrectomyPhase IIIRecruiting766
NCT03406650Neoadjuvant and Adjuvant Durvalumab in Combination With Neoadjuvant Chemotherapy in Patients With Operable Urothelial Cancer. (SAKK 06/17)Phase IIRecruiting61
NCT02845323Neoadjuvant Nivolumab With and Without Urelumab in Patients With Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the BladderPhase IIRecruiting22
NCT03234153Neoadjuvant Immunotherapy With Durvalumab and Tremelimumab for Bladder Cancer Patients Ineligible for Cisplatin (NITIMIB)Phase IIRecruiting68
NCT02736266Neoadjuvant Pembrolizumab for Muscle-invasive Urothelial Bladder CarcinomaPhase IIRecruiting90
NCT03387761Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO)Phase IRecruiting24
NCT02812420Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before SurgeryPhase IRecruiting35
NCT02762006Neoadjuvant MEDI 4736 ± Tremelimumab in Locally Advanced Renal Cell CarcinomaPhase IRecruiting45
NCT02575222Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell CarcinomaPhase IActive, not recruiting30
NCT02595918Nivolumab in Treating Patients With High-Risk Non-Metastatic Kidney CancerPhase IRecruiting29
Breast cancer
NCT03639948Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NeoPACT)Phase IIRecruiting100
NCT02957968Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast CaPhase IIRecruiting50
NCT02997995Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure (ULTIMATE)Phase IIRecruiting240
NCT02489448Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast CancerPhase I/IIRecruiting61
NCT02999477A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast CancerPhase IRecruiting50
NCT02833233A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast CancerPhase IActive, not recruiting5
Ovarian cancer
NCT03249142Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer (INeOV)Phase I/IIRecruiting66
Gastroesophageal cancers
NCT03448835Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)Phase IIRecruiting20
NCT02918162Perioperative Chemo and Pembrolizumab in Gastric CancerPhase IIRecruiting40
NCT02735239Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal CancerPhase I/IIRecruiting75
NCT03044613Nivolumab ± Relatlimab Prior to Chemoradiation Plus Nivolumab ± Relatlimab With II/III Gastro/Esophageal CancerPhase IRecruiting32
Colorectal cancer
NCT03026140Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity (NICHE)Phase IIRecruiting60
NCT02948348Study to Nivolumab Following Preoperative ChemoradiotherapyPhase I/IIRecruiting50
NCT03127007Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer (R-IMMUNE)Phase I/IIRecruiting54
NCT02754856Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver MetastasesPhase IRecruiting35
Hepatocellular carcinoma
NCT03299946Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)Phase IRecruiting15
Pancreatic cancer
NCT02305186Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer (UVA-PC-PD101)Phase I/IIRecruiting56
NCT02930902Preoperative Pilot Study to Assess Safety and Immunological Effect of Pembrolizumab (Keytruda) in Combination With Paricalcitol With or Without Chemotherapy in Patients With Resectable Pancreatic CancerPhase IRecruiting30
NCT03153410Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the PancreasPhase IRecruiting12
Sarcoma
NCT03116529Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma (NEXIS)Phase I/IIRecruiting35