- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, Metastases: CA224-094: Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma (clinicaltrials.gov) - Nov 30, 2023
P2, N=27, Active, not recruiting,
No abstract available Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Journal, Immunomodulating: A Comparison of the Antitumor Efficacy of Novel Multi-Specific Tribodies with Combinations of Approved Immunomodulatory Antibodies. (Pubmed Central) - Nov 25, 2023
When tested for their functional properties, they showed an increased ability to induce lymphocyte activation and stronger in vitro cytotoxicity against tumor cells compared to combinatorial treatments of clinically validated mAbs. Considering that tribodies also have other advantages with respect to combinatorial treatments, such as reduced production costs and lower dose requirements, we think that these novel immunomodulatory TRs could be used for therapeutic applications, particularly in monotherapy-resistant cancer patients.
- |||||||||| Review, Journal, Checkpoint inhibition, Checkpoint block: Educational Review: Clinical Application of Immune Checkpoint Blockade for the Treatment of Melanoma. (Pubmed Central) - Nov 22, 2023
Furthermore, we discuss the rationale for the applications of PD-1 blockade and its combination with anti-CTLA-4 and anti-LAG-3. The review also explores new experimental combinations of PD-1 blockade with other immunomodulatory agents, including targeted therapies, anti-TIGIT antibodies, TLR-9 agonists, antiangiogenic agents, and mRNA vaccines.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, fianlimab (REGN3767) / Regeneron, Sanofi
Journal: What role can LAG-3-blocking antibodies play in melanoma therapy? (Pubmed Central) - Nov 8, 2023
The review also explores new experimental combinations of PD-1 blockade with other immunomodulatory agents, including targeted therapies, anti-TIGIT antibodies, TLR-9 agonists, antiangiogenic agents, and mRNA vaccines. No abstract available
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Combination therapy, Metastases: Nivolumab/Relatlimab-rmbw: A Novel Dual Combination Therapy to Treat Adult and Pediatric Patients With Unresectable or Metastatic Melanoma. (Pubmed Central) - Nov 5, 2023
No safety concerns were observed compared with monotherapy with treatment-related adverse events occurring in 18.9% of patients on combination therapy compared with 9.7% on nivolumab alone. The novel mechanism and improvement in progression-free survival compared with standard of care highlight the therapeutic advancement of nivolumab/relatlimab-rmbw in the treatment of unresectable and metastatic melanoma.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial initiation date, Trial primary completion date, Checkpoint inhibition, Metastases: Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (clinicaltrials.gov) - Oct 31, 2023
P1, N=33, Not yet recruiting,
The novel mechanism and improvement in progression-free survival compared with standard of care highlight the therapeutic advancement of nivolumab/relatlimab-rmbw in the treatment of unresectable and metastatic melanoma. Trial completion date: Sep 2029 --> Mar 2030 | Initiation date: Sep 2023 --> Mar 2024 | Trial primary completion date: Dec 2027 --> Jun 2028
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: The role of diabetes in metastatic melanoma patients treated with nivolumab plus relatlimab. (Pubmed Central) - Oct 30, 2023
LAG3 inhibition for treating metastatic or unresectable melanoma has a reduced efficacy in patients with type 2 diabetes, possibly due to a low expression of LAG3 in tumor tissue. Higher level evidence should be obtained.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Advancement of anti-LAG-3 in cancer therapy. (Pubmed Central) - Oct 22, 2023
Clinical data suggests that anti-LAG-3 agents can amplify the therapeutic response of other immune checkpoint inhibitors with manageable side effects. In this review, we elucidate the intercellular and intracellular mechanisms of LAG-3, clarify the current understanding of LAG-3 in the tumor microenvironment, identify present LAG-3-associated therapeutic agents, discuss current LAG-3-involving clinical trials, and eventually address future prospects for LAG-3 inhibitors.
- |||||||||| 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.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, Mismatch repair, Metastases: Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor (clinicaltrials.gov) - Oct 10, 2023
P2, N=42, Recruiting,
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. Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Yervoy (ipilimumab) / BMS
Trial completion, Combination therapy, Metastases: A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment (clinicaltrials.gov) - Oct 1, 2023
P1/2, N=11, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion, Trial completion date, Checkpoint inhibition, Checkpoint block: Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade (clinicaltrials.gov) - Sep 21, 2023
P1, N=21, Completed,
1 We interrogated transcriptional and TCR clonal dynamics of head and neck squamous cell carcinoma (HNSCC) patients who received neoadjuvant nivolumab (anti-PD1) Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Lorbrena (lorlatinib) / Pfizer, Keytruda (pembrolizumab) / Merck (MSD)
Forecasting the future impact of novel therapies on cancer treatment in Australia (Meeting Room 103) - Sep 18, 2023 - Abstract #COSA2023COSA_546;
Hence, the addition of pembrolizumab to the first-line treatment regimen appears to offer clinical benefits to patients without significantly escalating treatment demand over a 5-year time horizon. Other HS outputs, such as relatlimab in melanoma and lorlatinib in NSCLC, were used to predict future impact.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial primary completion date, Checkpoint inhibition, Checkpoint block: Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade (clinicaltrials.gov) - Sep 8, 2023
P1, N=20, Active, not recruiting,
Other HS outputs, such as relatlimab in melanoma and lorlatinib in NSCLC, were used to predict future impact. Trial primary completion date: Jan 2024 --> Apr 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Na (clinicaltrials.gov) - Sep 7, 2023
P2, N=42, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2027 | Trial primary completion date: Jul 2023 --> Jul 2027
- |||||||||| Empliciti (elotuzumab) / AbbVie, BMS, relatlimab (BMS-986016) / BMS, renvistobart (BMS-986207) / BMS
Enrollment closed, Enrollment change, Trial primary completion date, Immuno-oncology: Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT (clinicaltrials.gov) - Jul 31, 2023
P1/2, N=14, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Jul 2027 | Trial primary completion date: Jul 2023 --> Jul 2027 Recruiting --> Active, not recruiting | N=104 --> 14 | Trial primary completion date: Dec 2024 --> Dec 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Endoscopic Ultrasound With Fine Needle Biopsy Confirming a Diagnosis of Immune Checkpoint Inhibitor-Related Type III Autoimmune Pancreatitis (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_3381;
Case Description/ A 71-year-old male with metastatic mucosal melanoma of the urethra (on palliative nivolumab/relatlimab) complicated by adrenal insufficiency and microscopic colitis developed vague epigastric discomfort and elevated amylase and lipase (20x ULN)...He was treated symptomatically and started on prednisone 40 mg daily for type III AIP, with plans for a slow taper...Fine needle biopsy 22-gauge core needle is seen entering the mass. Panel C: Hematoxylin and Eosin stained-pathology slide showing pancreatic acinar structures infiltrated with lymphocyte-predominant, mixed inflammatory infiltrates, with acinar damage and dropout.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Metastatic Melanoma Involving the Gastrointestinal Tract (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_3258;
Therefore, close attention to GI symptoms followed by imaging and endoscopic evaluation can result in earlier intervention and progression-free survival. Figure: Left: PET scan with relative thickening of the mid to distal gastric walls with associated focal uptake Right: EGD findings of two ulcerated polypoid masses in the anterior wall of the stomach measuring 4cm (top) and 1.5cm (bottom)
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
A Case of Metastatic Melanoma to the Colon Presenting With Intussusception (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_681;
Our case is of interest because the patient was symptomatic and also did not present with any bleeding. Figure: Pathology demonstrating (A) necrosis, (B) ulceration, (C) melan A and (D) SOX10 positivity.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma, Yervoy (ipilimumab) / Ono Pharma, BMS
Metastasis Pancreatic Melanoma First Presenting as Asymptomatic Isolated Elevation of Alkaline Phosphatase Level (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_519;
As our patient had disseminated metastasis of malignant melanoma, he was started with combination therapy with nivolumab/relatlimab. Figure: A- PET scan showed large PET avid masses in the region of the pancreatic head B- PET CT showed approximately 7.7 cm pancreatic head region mass
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, ImmuFact (eftilagimod alpha) / Immutep
Review, Journal, Checkpoint inhibition: LAG-3 Inhibitors: Novel Immune Checkpoint Inhibitors Changing the Landscape of Immunotherapy. (Pubmed Central) - Jul 29, 2023
In this review, we discuss the structure of LAG-3, its mechanism of action, and its interaction with its ligands. We also shed light on the emerging treatments targeting LAG-3 for the treatment of solid tumors.
- |||||||||| Relapse free survival (RFS) at 3 years by pathological (path) response to neoadjuvant systemic treatment (NST) in patients (pts) with surgically resectable, high-risk melanoma () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2619;
P2
ICB trial arms were 8-9 wks of NST: nivolumab (nivo) (Arm A), ipilimumab 3mg/kg plus nivo 1mg/kg (Arm B) both followed by adjuvant nivo for 6 mo, and nivo + relatlimab (2 mos NST, 10 mos adjuvant) (Arm C)...Any path response to ICB NST (pCR, near pCR, pPR) is associated with improved RFS, but only pCR predicts durable RFS in TT NST. It is critical to understand associations between NST, path response, and outcomes to support personalization of adjuvant approaches and improve overall outcomes.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Neoadjuvant nivolumab plus relatlimab (anti-LAG3) in locally advanced MMR-deficient colon cancers: The NICHE-3 study (Burgos Auditorium - Hall 3) - Jul 27, 2023 - Abstract #ESMO2023ESMO_875;
P2
Conclusions Here we present data from NICHE-3, the first study showing the safety and efficacy of neoadjuvant nivolumab/relatlimab in dMMR colon cancer patients, with a pathologic response in all patients, including 79% pCR. Accrual is currently ongoing in stage 2, in which an additional 40 patients will be treated.
- |||||||||| Trial completion date: Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma (clinicaltrials.gov) - Jul 20, 2023
P1, N=36, 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 completion date: Dec 2024 --> Dec 2025
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial initiation date, Trial primary completion date, Checkpoint inhibition, Metastases: Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (clinicaltrials.gov) - Jul 17, 2023
P1, N=33, Not yet recruiting,
Trial completion date: Dec 2024 --> Dec 2025 Trial completion date: Jun 2029 --> Sep 2029 | Initiation date: Jun 2023 --> Sep 2023 | Trial primary completion date: Sep 2027 --> Dec 2027
- |||||||||| 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.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Combination therapy, Tumor mutational burden, IO biomarker: Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer (clinicaltrials.gov) - Jul 5, 2023
P2, N=60, Recruiting,
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. Trial completion date: Aug 2026 --> Jul 2025
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Beyond CTLA-4 and PD-1 Inhibition: Novel Immune Checkpoint Molecules for Melanoma Treatment. (Pubmed Central) - Jun 22, 2023
More than ten years after the approval of ipilimumab, immune checkpoint inhibitors (ICIs) against PD-1 and CTLA-4 have been established as the most effective treatment for locally advanced or metastatic melanoma, achieving durable responses either as monotherapies or in combinatorial regimens...The recent approval of anti-LAG-3 ICI, relatlimab, in combination with nivolumab for metastatic disease, has capitalized on the extensive research in the field and has highlighted the potential for further improvement of melanoma prognosis by synergistically blocking additional immune targets with new ICI-doublets, antibody-drug conjugates, or other novel modalities...Beginning from their immunomodulatory properties as co-inhibitory or co-stimulatory receptors, we present all therapeutic modalities targeting these molecules that have been tested in melanoma treatment either in preclinical or clinical settings. Better understanding of the checkpoint-mediated crosstalk between melanoma and immune effector cells is essential for generating more effective strategies with augmented immune response.
- |||||||||| Retrospective data, Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Activity and safety of first-line treatments for advanced melanoma: A network meta-analysis. (Pubmed Central) - Jun 19, 2023
Better understanding of the checkpoint-mediated crosstalk between melanoma and immune effector cells is essential for generating more effective strategies with augmented immune response. Relatlimab/nivolumab showed similar PFS and ORR compared to ipilimumab/nivolumab, with a trend for a better safety profile.
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment closed, Trial primary completion date, Combination therapy, Metastases, Immuno-oncology: REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer (clinicaltrials.gov) - Jun 15, 2023
P1/2, N=21, Active, not recruiting,
Relatlimab/nivolumab showed similar PFS and ORR compared to ipilimumab/nivolumab, with a trend for a better safety profile. Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2023 --> Dec 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, HEOR, Monotherapy, Metastases: Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. (Pubmed Central) - Jun 12, 2023
Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2023 --> Dec 2023 Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO?+?RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO?+?RELA as a first-line treatment option for patients with advanced melanoma.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial primary completion date, Combination therapy, Metastases: RELATIVITY-020: An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors (clinicaltrials.gov) - Jun 12, 2023
P1/2, N=1499, Active, not recruiting,
Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO?+?RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO?+?RELA as a first-line treatment option for patients with advanced melanoma. Trial primary completion date: Sep 2023 --> Sep 2024
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