- |||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Metastases: Five-Year Overall Survival with Ipilimumab and Stereotactic Ablative Radiotherapy for Metastatic Disease. (Pubmed Central) - Jun 5, 2023 P1/2 Combining ipilimumab with neoadjuvant nivolumab plus chemotherapy results in encouraging major pathologic response rates with no new safety signals in patients with operable NSCLC. Updated 5-year OS data from the phase II trial demonstrate the long-term clinical benefit of ipilimumab and SABR, which warrants further research and cumulative data.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Checkpoint inhibition: LAPTOP: Nivolumab, Ipilimumab and Chemoradiation in Pancreatic Cancer. (clinicaltrials.gov) - Jun 5, 2023 P1/2, N=40, Recruiting, Updated 5-year OS data from the phase II trial demonstrate the long-term clinical benefit of ipilimumab and SABR, which warrants further research and cumulative data. Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Jun 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Cured or Not? Long-term Outcomes of Immunotherapy Responders. Focus on Melanoma. (Pubmed Central) - Jun 2, 2023 Although the hope for cure seems reasonable for many patients in this situation, late relapses may occur and no relapse-predictive biomarkers have been identified yet. Long-term responders who relapse can respond to a rechallenge of ICI although data are limited concerning the rate and the duration of this new response.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: EA2201: Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer (clinicaltrials.gov) - Jun 2, 2023 P2, N=31, Suspended, Long-term responders who relapse can respond to a rechallenge of ICI although data are limited concerning the rate and the duration of this new response. Trial completion date: Sep 2023 --> Dec 2026 | Trial primary completion date: Sep 2023 --> Dec 2026
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer (clinicaltrials.gov) - Jun 2, 2023 P2, N=64, Active, not recruiting, Trial completion date: Sep 2023 --> Dec 2026 | Trial primary completion date: Sep 2023 --> Dec 2026 Trial completion date: May 2023 --> May 2025 | Trial primary completion date: May 2023 --> May 2025
- |||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Combination therapy, Checkpoint inhibition, IO biomarker, Checkpoint block: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Influence on Soluble and Membrane Bound ICOS in Combination with Immune Checkpoint Blockade. (Pubmed Central) - Jun 1, 2023 The addition of GM-CSF to ipilimumab has previously demonstrated both an improvement in efficacy and decrease in the incidence of high-grade adverse events...Whereas soluble ICOS plays a role in immune suppression, GM-CSF efficacy involves increasing membrane-bound ICOS and induction of dendritic cell development. Thus, soluble ICOS splice variants may be used as a biomarker for GM-CSF and immune checkpoint blockade-based therapies.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Yervoy (ipilimumab) / Ono Pharma, BMS
Triplet Strategies in Metastatic Clear Cell Renal Cell Carcinoma: A Worthy Option in the First-Line Setting? () - Jun 1, 2023 - Abstract #ASCO2023ASCO_7150; We present ongoing trials with an adaptive design that may serve as alternative methods for escalating from doublet to triplet regimens in the frontline setting and explore clinical factors and emerging predictive biomarkers (both baseline and dynamic) that may guide future trial design and frontline treatment for patients with advanced ccRCC. PRACTICAL APPLICATIONS: Combination therapy with dual immune checkpoint inhibitors or with a vascular endothelial growth factor receptor tyrosine kinase inhibitor and immune checkpoint inhibitor is the standard of care in the frontline setting for patients with advanced clear cell renal cell carcinoma (ccRCC).A triplet regimen consisting of ipilimumab, nivolumab, and cabozantinib demonstrated improved progression-free survival when compared with a doublet of ipilimumab and nivolumab at the cost of excess toxicity with unknown overall survival.Strategies to personalize therapy for ccRCC in the frontline setting, including response-adaptive treatment strategies and the use of biomarkers such as gene expression analysis to guide initial therapy, are under study.
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Metastases: CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov) - Jun 1, 2023 P2, N=30, Active, not recruiting, PRACTICAL APPLICATIONS: Combination therapy with dual immune checkpoint inhibitors or with a vascular endothelial growth factor receptor tyrosine kinase inhibitor and immune checkpoint inhibitor is the standard of care in the frontline setting for patients with advanced clear cell renal cell carcinoma (ccRCC).A triplet regimen consisting of ipilimumab, nivolumab, and cabozantinib demonstrated improved progression-free survival when compared with a doublet of ipilimumab and nivolumab at the cost of excess toxicity with unknown overall survival.Strategies to personalize therapy for ccRCC in the frontline setting, including response-adaptive treatment strategies and the use of biomarkers such as gene expression analysis to guide initial therapy, are under study. Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- |||||||||| Opdivo (nivolumab) / BMS, Actemra SC (tocilizumab SC) / Roche, Halozyme, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov) - May 31, 2023 P2, N=55, Recruiting, Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024 Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
- |||||||||| CBL137 IV / Incuron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial primary completion date: Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma (clinicaltrials.gov) - May 30, 2023 P1, N=12, Recruiting, In this case series, we outlined how in response to surgical delays secondary to the COVID-19 pandemic, NAT was successfully applied to achieve promising treatment response in patients with locally advanced stage III melanoma. Trial primary completion date: Nov 2024 --> Mar 2024
- |||||||||| Review, Journal, Checkpoint inhibition, Tumor mutational burden, Microsatellite instability, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker, Metastases: Immune checkpoint inhibition in advanced colorectal cancer with inherited and acquired microsatellite instability: Current state and future directions. (Pubmed Central) - May 29, 2023
Trial primary completion date: Nov 2024 --> Mar 2024 Overall, the outlook in advanced colorectal cancer patients with MSI appears optimistic as new and efficacious ICI drugs and combinations are being added to the existing therapeutic armamentarium.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Retrospective data, Review, Journal: Efficacy and safety of the combined use of ipilimumab and nivolumab for melanoma patients with brain metastases: a systematic review and meta-analysis. (Pubmed Central) - May 25, 2023 Incidence of grade 3/4 adverse events in IN-treated MBM patients was: diarrhea or colitis (16%), hepatitis (15%), rash (8%), increased alanine transaminase (8%), increased aspartate aminotransferase (7%), increased lipase (6%), increased amylase (4%), fatigue (3%), hypophysitis (2%), pneumonitis (2%), headache (2%), nausea or vomiting (1%), and neutropenia (1%). IN is an efficacious and safer treatment option for MBM patients, especially for asymptomatic and treatment na
- |||||||||| LN-145-S1 / Iovance Biotherap, LN-145 / Iovance Biotherap
Trial primary completion date: NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov) - May 24, 2023 P2, N=95, Recruiting, IN is an efficacious and safer treatment option for MBM patients, especially for asymptomatic and treatment na Trial primary completion date: Jun 2023 --> Jun 2024
- |||||||||| Tecentriq (atezolizumab) / Roche, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment closed, Trial completion date, Trial primary completion date, IO biomarker: ImmunoPET With an Anti-CD8 Imaging Agent (clinicaltrials.gov) - May 24, 2023 P1/2, N=47, Active, not recruiting, Trial primary completion date: Jun 2023 --> Jun 2024 Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Dec 2023
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Triplet Strategies in Metastatic Clear Cell Renal Cell Carcinoma: A Worthy Option in the First-Line Setting? (Pubmed Central) - May 23, 2023 There are multiple standard-of-care doublet regimens consisting of either the combined dual immune checkpoint inhibitors, ipilimumab and nivolumab, or combinations of a vascular endothelial growth factor receptor tyrosine kinase inhibitor and an immune checkpoint inhibitor...In this article, we discuss the role of doublet therapy as standard of care, the current data available for the promise of triplet therapy, the rationale to continue pursuing trials with triplet combinations, and factors for clinicians and patients to consider when choosing among frontline treatments. We present ongoing trials with an adaptive design that may serve as alternative methods for escalating from doublet to triplet regimens in the frontline setting and explore clinical factors and emerging predictive biomarkers (both baseline and dynamic) that may guide future trial design and frontline treatment for patients with advanced ccRCC.
- |||||||||| CD25hi Treg depleted DLI - Dana / Farber Cancer Institute
Trial completion date, Trial primary completion date: A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT (clinicaltrials.gov) - May 23, 2023 P1, N=25, Recruiting, We present ongoing trials with an adaptive design that may serve as alternative methods for escalating from doublet to triplet regimens in the frontline setting and explore clinical factors and emerging predictive biomarkers (both baseline and dynamic) that may guide future trial design and frontline treatment for patients with advanced ccRCC. Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2024
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change: CA209-8H3: Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients (clinicaltrials.gov) - May 23, 2023 P2, N=30, Active, not recruiting, Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2024 Recruiting --> Active, not recruiting | N=138 --> 30
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Yervoy (ipilimumab) / Ono Pharma, BMS
Clinical, Metastases: Cabozantinib, nivolumab& ipilimumab significantly lengthened PFS in patients with previously untreated, advanced #RCC who had intermediate or poor prognostic risk, according to the phase 3 COSMIC-313 trial. #kcsm | @DrChoueiri @DanaFarber_GU https://t.co/1GhJTtenGY (Twitter) - May 22, 2023
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