Yervoy (ipilimumab) News

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||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) -  Oct 27, 2023
P1, N=30, Recruiting,  Sponsor: City of Hope Medical Center
Trial completion date: Jan 2025 --> Mar 2026 | Trial primary completion date: Jan 2025 --> Mar 2026

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Adverse events, Checkpoint inhibition: Musculoskeletal adverse events induced by immune checkpoint inhibitors: a large-scale pharmacovigilance study. (Pubmed Central) - Oct 26, 2023
Furthermore, the combination therapy of nivolumab and ipilimumab does not result in a statistically significant escalation of the risk associated with the major musculoskeletal adverse events. Immune checkpoint inhibitors administration triggers a range of musculoskeletal adverse events, warranting the optimization of their management during clinical practice.

|||||||||| SD-101 / TriSalus Life Sci, UT MD Anderson Cancer Center
Clinical activity of SD-101 with immune checkpoint inhibition (ICI) in metastatic uveal melanoma liver metastasis (MUM-LM) from the PERIO-01 Phase 1 trial (Ground Level - Exhibit Hall C - San Diego) - Oct 25, 2023 - Abstract #SITC2023SITC_1920;
P1
PFS has been limited, even with approved therapies such as tebentafusp (median 3...Methods PERIO-01 is a phase 1 trial of hepatic arterial SD-101 via PEDD in MUM-LM (NCT04935229), with dose-escalation cohorts as monotherapy (Cohort A), with nivolumab (Cohort B), or nivolumab + ipilimumab (Cohort C)...7 months, MDSC re-programming, and evidence of peripheral and intra-tumoral immune activation. Phase 2 of PERIO-01 is planned for expansion of the optimal dose.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, SCIB1 / Scancell, Yervoy (ipilimumab) / Ono Pharma, BMS
A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: efficacy and safety results from the open-label phase 2 SCOPE trial (Exhibits Hall B) - Oct 25, 2023 - Abstract #SITC2023SITC_1919;
Conclusions SCIB1 in combination with nivolumab and ipilimumab as first line treatment for unresectable melanoma improved the ORR to 80% without an increase in clinically meaningful adverse events. These results if confirmed in a larger patient cohort provide confidence in initiating a randomised registration programme in unresectable melanoma patients with our novel DNA plasmid technology.

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  CHINOREC: Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer (clinicaltrials.gov) -  Oct 24, 2023
P2, N=80, Recruiting,  Sponsor: Johannes Laengle, MD, PhD
These results if confirmed in a larger patient cohort provide confidence in initiating a randomised registration programme in unresectable melanoma patients with our novel DNA plasmid technology. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Jun 2024

||||||||||  volrustomig (MEDI5752) / AstraZeneca
New P3 trial:  eVOLVE-Meso: MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma (clinicaltrials.gov) -  Oct 23, 2023
P3, N=600, Not yet recruiting,  Sponsor: AstraZeneca

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
New P1 trial:  NEO-GLITIPNI: A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma (clinicaltrials.gov) -  Oct 23, 2023
P1, N=18, Not yet recruiting,  Sponsor: Universitair Ziekenhuis Brussel

||||||||||  lefitolimod (MGN1703) / Feng Biosciences, iPharma, Gilead, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Metastases:  Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) -  Oct 23, 2023
P1, N=28, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Jun 2024 Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2025

||||||||||  sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies (clinicaltrials.gov) -  Oct 23, 2023
P1, N=92, Active, not recruiting,  Sponsor: Mirati Therapeutics Inc.
Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2025 Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Jun 2023

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed:  Observational Study in Patients With Previously Unresectable Malignant Pleural Mesothelioma Treated With Nivolumab and Ipilimumab (MESO-IMMUNE) (clinicaltrials.gov) -  Oct 23, 2023
P=N/A, N=200, Active, not recruiting,  Sponsor: Groupe Francais De Pneumo-Cancerologie
Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Jun 2023 Not yet recruiting --> Active, not recruiting

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment open:  G360-IIT: Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy (clinicaltrials.gov) -  Oct 23, 2023
P2, N=108, Recruiting,  Sponsor: Hackensack Meridian Health
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker, Checkpoint block: Subsets of interferon signaling predict response to immune checkpoint blockade in melanoma patients. (Pubmed Central) - Oct 23, 2023
When combining STAT1 and PD-L1 markers, patients with STAT1highPD-L1low tumors had improved survival compared with those with STAT1lowPD-L1high tumors. > STAT1 may better predict melanoma response to ICIs than current strategies, and combined STAT1 and PD-L1 biomarkers may provide insight into IFN-responsive versus IFN-resistant states.

|||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Metastases: Health-state utilities in long-term advanced melanoma survivors comparable with the general population. (Pubmed Central) - Oct 23, 2023
> STAT1 may better predict melanoma response to ICIs than current strategies, and combined STAT1 and PD-L1 biomarkers may provide insight into IFN-responsive versus IFN-resistant states. Our results show that long-term advanced melanoma survivors treated with ipilimumab monotherapy experience relatively stable and high health-state utility scores.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Biomarker, Journal, Metastases, Immuno-oncology: Clinico-Pathological Features Influencing the Prognostic Role of Body Mass Index in Patients With Advanced Renal Cell Carcinoma Treated by Immuno-Oncology Combinations (ARON-1). (Pubmed Central) - Oct 23, 2023
P=N/A
Our results show that long-term advanced melanoma survivors treated with ipilimumab monotherapy experience relatively stable and high health-state utility scores. Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, HEOR, Cost-effectiveness, Cost effectiveness: First-line nivolumab plus ipilimumab for unresectable MPM in China: a cost-effectiveness analysis. (Pubmed Central) - Oct 22, 2023
P3
Our study suggests that the prognostic significance and the association of BMI with treatment outcome varies across clinico-pathological mRCC subgroups. From the perspective of the Chinese healthcare system, in patients with unresectable MPM, NI has no economic advantage over C.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Metastases: Hyperprogression in advanced melanoma is not restricted to immunotherapy. (Pubmed Central) - Oct 22, 2023
This data, thanks to relevant clinical and biological criteria feasible in daily practice, supports the presence of a subgroup whose disease deteriorates rapidly during mono-immunotherapy. Also observed with other treatments, HPD could be the consequence of a natural and aggressive evolution of the disease, alleviated by strong-acting treatments.

|||||||||| Journal, PD(L)-1 Biomarker, IO biomarker: Systemic Therapy for Melanoma: ASCO Guideline Update. (Pubmed Central) - Oct 22, 2023
Talimogene laherparepvec is no longer recommended as an option for patients with BRAF wild-type disease who have progressed on anti-PD-1 therapy. Ipilimumab- and ipilimumab-containing regimens are no longer recommended for patients with BRAF-mutated disease after progression on other therapies.This full update incorporates the new recommendations for uveal melanoma published in the 2022 Rapid Recommendation Update.Additional information is available at www.asco.org/melanoma-guidelines.

|||||||||| Cavatak (gebasaxturev) / Merck (MSD), Yervoy (ipilimumab) / Ono Pharma, BMS
P1 data, Journal, Metastases: Phase 1b study of intravenous coxsackievirus A21 (V937) and ipilimumab for patients with metastatic uveal melanoma. (Pubmed Central) - Oct 22, 2023
P1b
Ipilimumab- and ipilimumab-containing regimens are no longer recommended for patients with BRAF-mutated disease after progression on other therapies.This full update incorporates the new recommendations for uveal melanoma published in the 2022 Rapid Recommendation Update.Additional information is available at www.asco.org/melanoma-guidelines. Although the combination of V937 with ipilimumab had a manageable safety profile, meaningful clinical benefit was not observed in patients with uveal melanoma and liver metastases.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker: Combinational expression of tumor testis antigens NY-ESO-1, MAGE-A3, and MAGE-A4 predicts response to immunotherapy in mucosal melanoma patients. (Pubmed Central) - Oct 22, 2023
Although the combination of V937 with ipilimumab had a manageable safety profile, meaningful clinical benefit was not observed in patients with uveal melanoma and liver metastases. In conclusion, these three biomarkers await validation in a larger patient cohort and could be easily used in future routine diagnostics to predict the outcome of ipilimumab/nivolumab combination therapy in mucosal melanoma patients.

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Biomarker, Enrollment closed, Trial completion date, Checkpoint inhibition, Tumor mutational burden, IO biomarker:  BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer (clinicaltrials.gov) -  Oct 19, 2023
P2, N=90, Active, not recruiting,  Sponsor: Lung Cancer Group Cologne
In conclusion, these three biomarkers await validation in a larger patient cohort and could be easily used in future routine diagnostics to predict the outcome of ipilimumab/nivolumab combination therapy in mucosal melanoma patients. Enrolling by invitation --> Active, not recruiting | Trial completion date: Sep 2023 --> Dec 2023

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Checkpoint inhibition:  Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers (clinicaltrials.gov) -  Oct 19, 2023
P1, N=12, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Enrolling by invitation --> Active, not recruiting | Trial completion date: Sep 2023 --> Dec 2023 Trial completion date: Mar 2024 --> Sep 2024

|||||||||| DNAJB1-PRKACA peptide vaccine / BMS, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
A DNAJB1-PRKACA fusion peptide vaccine combined with ipilimumab and nivolumab elicits polyclonal fusion-specific T cell responses in fibrolamellar carcinoma (Exhibit Hall B) - Oct 19, 2023 - Abstract #SITC2023SITC_1852;
P1
Our studies provide a framework to identify these responses in peripheral blood samples from treated patients and thereby determine correlates of response to therapy. Additionally, the defined fusion-specific TCRs show potential for translation to cellular therapies for FLC, highlighting multiple immunotherapeutic strategies that could benefit FLC patients.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Reinvigoration of progenitor-exhausted CD8 T cells by anti-CTLA-4 contributes to the sustained activity of combination checkpoint blockade (Exhibit Hall B) - Oct 19, 2023 - Abstract #SITC2023SITC_1837;
Conclusions First, durable immune responses represent waves of immune responses generated by different T cell clones. Second, progenitor TEX induced by CTLA-4 blockade may contribute to durable immune responses through self-renewal and replenishing of the TEX pool.

||||||||||  CIML NK - Dana / Farber Cancer Institute
Trial primary completion date, Combination therapy, Metastases, Immune cell:  CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) -  Oct 17, 2023
P1, N=25, Recruiting,  Sponsor: Dana-Farber Cancer Institute
Second, progenitor TEX induced by CTLA-4 blockade may contribute to durable immune responses through self-renewal and replenishing of the TEX pool. Trial primary completion date: Sep 2023 --> Jan 2024

||||||||||  Selzentry (maraviroc) / ViiV Healthcare, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion:  Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer the LUMINESCENCE Trial (clinicaltrials.gov) -  Oct 17, 2023
P1, N=50, Completed,  Sponsor: University Hospital Heidelberg
Trial primary completion date: Sep 2023 --> Jan 2024 Active, not recruiting --> Completed

||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, IO biomarker:  SiCARIO: Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer (clinicaltrials.gov) -  Oct 17, 2023
P1/2, N=25, Recruiting,  Sponsor: Vanderbilt-Ingram Cancer Center
Active, not recruiting --> Completed Suspended --> Recruiting

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Checkpoint inhibition:  Nivolumab, Ipilimumab and Chemoradiation in Treating Patients with Resectable Gastric Cancer (clinicaltrials.gov) -  Oct 16, 2023
P2, N=32, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Suspended --> Recruiting Trial completion date: Sep 2023 --> Dec 2026 | Trial primary completion date: Sep 2023 --> Dec 2026

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS, plinabulin (BPI 2358) / BeyondSpring
Enrollment closed, Trial completion date:  BTCRC-LUN17-127: A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov) -  Oct 16, 2023
P1/2, N=39, Active, not recruiting,  Sponsor: Salma Sabbour
Trial completion date: Sep 2023 --> Dec 2026 | Trial primary completion date: Sep 2023 --> Dec 2026 Recruiting --> Active, not recruiting | Trial completion date: Sep 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) -  Oct 16, 2023
P2, N=55, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Jan 2024 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

||||||||||  Opdivo (nivolumab) / BMS, Cabometyx (cabozantinib tablet) / Exelixis, Yervoy (ipilimumab) / BMS
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, Tumor mutational burden, IO biomarker:  Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma (clinicaltrials.gov) -  Oct 16, 2023
P2, N=66, Recruiting,  Sponsor: National Cancer Institute (NCI)
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> May 2026 | Initiation date: Sep 2023 --> Jun 2024 | Trial primary completion date: Jun 2025 --> May 2026

|||||||||| Review, Journal: Overview, Diagnosis, and Perioperative Systemic Therapy of Upper Tract Urothelial Carcinoma. (Pubmed Central) - Oct 14, 2023
With the FDA approval of erdafitinib in metastatic urothelial carcinoma, similar targets have been explored for use in perioperative use in invasive urothelial carcinoma, as with adjuvant infigratinib in the PROOF-302 trial. As the treatment paradigm for urothelial carcinoma evolves, further prospective studies are needed to expand the perioperative treatment landscape of UTUC.

|||||||||| Trial completion date, Trial primary completion date: International Multicentric Study ARON-1 (clinicaltrials.gov) - Oct 13, 2023
P=N/A, N=1220, Recruiting, Sponsor: Hospital of Macerata
As the treatment paradigm for urothelial carcinoma evolves, further prospective studies are needed to expand the perioperative treatment landscape of UTUC. Trial completion date: Nov 2022 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Jun 2024

|||||||||| Uptake and efficacy of immuno-oncology combinations in metastatic renal cell carcinoma in the United States: Evidence from the ASCO CancerLinQ Discovery database. (3rd Floor, Back Bay Hall; Poster Bd #: L7) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_583;
Compared to progression-free survival (PFS) from the landmark trials, this analysis demonstrated shorter TTD, indicating either underestimation of the true PFS or worse outcomes in a non-clinical trial setting. Integration of radiologic response into this dataset could help clarify outcomes.

|||||||||| Real-world data on immune-checkpoint inhibitors use and immune-related adverse events in lung cancer. (3rd Floor, Back Bay Hall; Poster Bd #: D3) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_422;
Our findings suggested that in the real world, older patients, patients with ADs, and patients with poor performance had no significant delays in ICIs initiation. The pattern of irAEs was similar to that reported in clinical trials without erosion of OS among those with irAEs.

|||||||||| Real-world analysis of biomarker testing and actionability in metastatic colorectal cancer (mCRC) in the United States (US). (3rd Floor, Back Bay Hall; Poster Bd #: B22) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_384;
Current real-world biomarker testing rates reflect increased adoption of clinical guideline recommendations, leading to improved treatment actionability as shown by sustained administration of targeted therapies (BRAF), increased administration of immunotherapy (MSI-H), and less frequent use of potentially inappropriate treatments (RAS). Further improvements in testing and receipt of appropriate therapies may lead to better patient outcomes.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Operationalization of decentralized clinical trials: The BrUOG354 experience. (3rd Floor, Back Bay Hall; Poster Bd #: B7) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_369;
P2
Therapeutic DCTs are feasible and heightened capacity for future patient-centric trial designs is an exciting prospect. For these to succeed, the ability to conduct study visits by telehealth, especially for out of state residents, is critical.

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion, Trial completion date, Trial primary completion date:  Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) -  Oct 12, 2023
P2, N=149, Completed,  Sponsor: M.D. Anderson Cancer Center
For these to succeed, the ability to conduct study visits by telehealth, especially for out of state residents, is critical. Recruiting --> Completed | Trial completion date: Apr 2024 --> Oct 2023 | Trial primary completion date: Apr 2024 --> Oct 2023

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma (clinicaltrials.gov) -  Oct 11, 2023
P2, N=113, Recruiting,  Sponsor: National Cancer Centre, Singapore
Recruiting --> Completed | Trial completion date: Apr 2024 --> Oct 2023 | Trial primary completion date: Apr 2024 --> Oct 2023 Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed:  GlitIpNi: Intra-tumoral Ipilimumab Plus Intravenous Nivolumab Following the Resection of Recurrent Glioblastoma (clinicaltrials.gov) -  Oct 11, 2023
P1, N=110, Active, not recruiting,  Sponsor: Universitair Ziekenhuis Brussel
Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024 Recruiting --> Active, not recruiting

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal: Surgical Outcomes After Chemotherapy plus Nivolumab and Chemotherapy plus Nivolumab and Ipilimumab in Patients with Non-Small Cell Lung Cancer. (Pubmed Central) - Oct 10, 2023
Surgical resections are feasible and safe, with high rates of R0 following neoadjuvant chemotherapy and nivolumab with or without ipilimumab. Overall, approximately half of cases (22/42, 52.3%) were considered to be more challenging than a standard lobectomy (Figure 4).

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  SUNNIFORECAST: Randomized Phase-II Study of Nivolumab Plus Ipilimumab vs. Standard of Care in Untreated and Advanced Non-clear Cell RCC (clinicaltrials.gov) -  Oct 10, 2023
P2, N=316, Active, not recruiting,  Sponsor: Goethe University
Overall, approximately half of cases (22/42, 52.3%) were considered to be more challenging than a standard lobectomy (Figure 4). Trial completion date: Feb 2025 --> May 2024 | Trial primary completion date: Nov 2024 --> Nov 2023

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma (clinicaltrials.gov) -  Oct 10, 2023
P1/2, N=94, Recruiting,  Sponsor: Ravi Amaravadi, MD
Trial completion date: Feb 2025 --> May 2024 | Trial primary completion date: Nov 2024 --> Nov 2023 Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2023 --> Oct 2025

||||||||||  Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date:  Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary (clinicaltrials.gov) -  Oct 10, 2023
P1, N=22, Recruiting,  Sponsor: Abramson Cancer Center at Penn Medicine
Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2023 --> Oct 2025 Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Nov 2023

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Tecentriq (atezolizumab) / Roche, Yervoy (ipilimumab) / Ono Pharma, BMS
Clinical, Journal, Checkpoint inhibition: Survival benefit with checkpoint inhibitors versus chemotherapy is modified by brain metastases in patients with recurrent small cell lung cancer. (Pubmed Central) - Oct 9, 2023
Most patients (93%) in the CPI group received nivolumab/ipilimumab. Chemotherapy patients were entirely CPI-na

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Combination therapy with anti-PD-1 antibody plus angiokinase inhibitor exerts synergistic antitumor effect against malignant mesothelioma via tumor microenvironment modulation (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_1040;
Co-administration of anti-PD-1 Ab may reactivate phagocytic activity of BMDMs by disrupting nintedanib-induced immunosuppressive signal. Conclusions Combination therapy of anti-PD-1 Ab plus nintedanib exerts synergistic antitumor activity and can become a novel therapeutic option for patients with MPM.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
The changes of the serum SMRP levels is useful to predict the antitumor efficacy of ipilimumab plus nivolumab combination therapy in patients with malignant pleural mesothelioma (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_1026;
Conclusions Our results suggested that changes in serum SMRP levels was useful in determining the efficacy of ICI treatment. We are planning to accumulate more cases in the future for further investigation.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Decoding the intricate cellular makeup of immune-related adverse events using single-cell and spatial analysis (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_931;
P1/2
Conclusions This pilot analysis provides valuable insights into the multi-omic signatures associated with the irAEs. The ongoing recruitment in NCT04631731 holds promise for successful validation of preliminary data thus providing new perspectives on establishing biomarkers of immunotherapy toxicity in the near future.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Efficacy and safety of first-line combination therapy with ipilimumab + nivolumab for metastatic renal cell carcinoma in a single institution in Japan (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_799;
Conclusions IO-Combo treatment for metastatic RCC was performed effectively and safely in Japanese patients. Surgical CR may be achieved with DCN after IO combination therapy even in poor-risk patients, but there is a possibility that Ipilimumab plus Nivolumab treatment has weak efficacy for non-clear cell RCC.

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
A prospective observational study of MSI screening in unresectable chemotherapy-na (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_712;
Surgical CR may be achieved with DCN after IO combination therapy even in poor-risk patients, but there is a possibility that Ipilimumab plus Nivolumab treatment has weak efficacy for non-clear cell RCC. We conducted a prospective observational study as screening for WJOG13320G, a single arm phase 2 trial of Nivolumab plus low dose Ipilimumab (jRCT2080225304), and to clarify the prevalence and clinicopathological features of chemotherapy-na

|||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap, Yervoy (ipilimumab) / Ono Pharma, BMS
NEXUS: A phase I dose escalation study of selinexor plus nivolumab and ipilimumab in Asian patients with advanced/metastatic solid malignancies (Exhibition area) - Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_660;
P1
The combination showed promising anti-tumor activity in Asian patients with advanced malignancies who had failed prior immunotherapy, and merits further investigation. Translational studies are underway.



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