- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Surgery after Neoadjuvant Immuno-Chemoradiotherapy in (Borderline) Resectable NSCLC: Results from the INCREASE Trial (Summit 1) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1007; Neoadjuvant dual immunotherapy and concurrent chemoradiotherapy resulted in very high MPR and pCR rates, did not interfere with pulmonary resection, and no excess in early morbidity and mortality was observed when compared to previous institutional cohorts treated with CRT alone. Longer follow-up to assess toxicity, as well as translational analyses regarding the immunological effects of this induction scheme, are needed in order to interpret the clinical potential of this approach in (borderline) resectable NSCLC.Characteristics of evaluable patients in the INCREASE trialn (n%)Sex (male:female)11:14Age (years, median (iqr))64 (55-69)HistologyAdenocarcinoma12 (48%)Squamous cell carcinoma7 (28%)Large-cell NOS5 (20%)Large-cell neuroendocrine1 (4%)Tumor stage (8th TNM edition)Stage IIB T3N05 (20%)Stage IIIA T3N14 (16%)Stage IIIA T4N012 (48%)Stage IIIA T4N13 ((12%)Stage IIIB T3N21 (4%)Invasive mediastinal staging None3 (12%)EBUS17 (68%)EUS2 (8%)EBUS+EUS2 (8%)Mediastinoscopy1 (4%)Radiotherapy dose50Gy22 (88%)60Gy3 (12%)Time from last radiotherapy to surgery (days, median (iqr))43 (41-44)Chest wall invasion11 (44%)Sulcus superior tumors7Other4Pulmonary resectionLobectomy13 (52%)Lobectomy + thoracic wall10 (40%)Lobectomy + thoracic wall + partial vertebrectomy1 (4%)Pneumonectomy1 (4%)Resection margin R025 (100%)Pathological responsepCR15 (60%)MPR19 (76%)No MPR6 (24%)Postoperative morbidityAny grade16 (64%)Grade 1-211 (44%)Grade 3-45 (20%)Wound dehiscence1 (+readmission <30days)Atelectasis2Pancreatitis1Empyema1 (+readmission <30days)Hospital stay (days, median (iqr))6 (5-9)NOS = not otherwise specified, iqr = interquartile range, EBUS = endobronchial bronchial ultrasound,EUS = esophageal ultrasound, Gy = Gray, R0 = radical resection margin, pCR = pathological complete response,MPR = major pathological response
- |||||||||| Tibsovo (ivosidenib) / Servier
Trial primary completion date: Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma (clinicaltrials.gov) - Jul 22, 2023 P1/2, N=92, Not yet recruiting, The low toxicity of the combination may also allow for further layering of additional therapeutic approaches such as chemotherapy, oncolytic viruses, cellular therapies, and possibly novel cytokines, among others. Trial primary completion date: Nov 2023 --> Mar 2026
- |||||||||| Opdivo (nivolumab) / BMS, BMS-986156 / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Tumor mutational burden: BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers (clinicaltrials.gov) - Jul 21, 2023 P1/2, N=68, Active, not recruiting, Trial primary completion date: Nov 2023 --> Mar 2026 Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma (clinicaltrials.gov) - Jul 21, 2023 P2, N=10, Active, not recruiting, Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024 Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial primary completion date, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Jul 20, 2023 P1, N=12, Recruiting, Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025 Trial primary completion date: Jun 2023 --> Sep 2023
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal: Bispecific antibodies targeting CTLA-4: game-changer troopers in cancer immunotherapy. (Pubmed Central) - Jul 17, 2023 This article will summarize BsAbs targeting CTLA-4, their applications in cancer immunotherapy, and relevant clinical trial advances. We will also discuss the pre-clinical rationale for using these BsAbs, and provide the current landscape of the field.
- |||||||||| Journal, PD(L)-1 Biomarker, IO biomarker: Adjuvant therapy for stage II melanoma: the need for further studies. (Pubmed Central) - Jul 17, 2023
We will also discuss the pre-clinical rationale for using these BsAbs, and provide the current landscape of the field. In the metastatic setting, patients treated with nivolumab and ipilimumab have an expected 5-year survival of>
- |||||||||| Trial completion date, Trial primary completion date, IO biomarker: MEMBRAINS: Melanoma Metastasized to the Brain and Steroids (clinicaltrials.gov) - Jul 13, 2023
P2, N=80, Recruiting, Other BRAF, NRAS, or NF1 mutations were not associated with significant differences in outcome. Trial completion date: Jun 2025 --> Jun 2028 | Trial primary completion date: Jun 2023 --> Jun 2024
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion, Enrollment change, Trial primary completion date: Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer (clinicaltrials.gov) - Jul 13, 2023 P2, N=101, Completed, Trial completion date: Jun 2025 --> Jun 2028 | Trial primary completion date: Jun 2023 --> Jun 2024 Active, not recruiting --> Completed | N=220 --> 101 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| Opdivo (nivolumab) / BMS, Aliqopa (copanlisib) / Bayer, Yervoy (ipilimumab) / BMS
Biomarker, Enrollment closed, Checkpoint inhibition, IO biomarker: Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (clinicaltrials.gov) - Jul 12, 2023 P1/2, N=102, Active, not recruiting, Trial completion date: Jul 2023 --> Aug 2027 Recruiting --> Active, not recruiting
- |||||||||| Opdivo (nivolumab) / BMS, Aliqopa (copanlisib) / Bayer, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma (clinicaltrials.gov) - Jul 6, 2023 P1, N=64, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Jun 2025 --> Apr 2023 | Trial primary completion date: Feb 2025 --> Apr 2023 Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Nivolumab plus ipilimumab in metastatic melanoma: a critical appraisal focused on specific subpopulations. (Pubmed Central) - Jul 5, 2023 We also explore the benefit of the combination schedule across different subgroups of patients and possible predictive biomarkers for efficacy outcomes in order to elucidate which patients could be the best candidates for combination or single-agent therapy. Patients with BRAF-mutant tumours, asymptomatic brain metastases, or PD-L1-negative status appear to reach better survival outcomes with the combination relative to single-agent immunotherapy.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors (clinicaltrials.gov) - Jul 3, 2023 P2, N=9, Active, not recruiting, Initiation date: Jan 2023 --> Jun 2023 Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
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