Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Capecitabine

Bevacizumab

Pemetrexed

Pembrolizumab

Leucovorin

Fluorouracil

Temozolomide

Nivolumab

Oxaliplatin

Daratumumab

Ipilimumab

Relatlimab

Sunitinib

Trametinib

Rucaparib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Enzyme Inhibitors

Folic Acid Antagonists

Antineoplastic Agents, Alkylating

Alkylating Agents

Protein Kinase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Folate

Vitamin B9

Folinic Acid

Cabozantinib

Nivolumab + Relatlimab

Regorafinib

Enzalutamide

BMS Study Connect Contact http://www.bmsstudyconnect.com/

First line of the email MUST contain NCT# and Site#

Adil Daud, Site 0099

Thomas Flaig, Site 0233

Site 0095

Michael Atkins, Site 0088

Nikhil Khushalani, Site 0024

Sigrun Hallmeyer, Site 0279

Chao Huang, Site 0186

Shaker Dakhil, Site 0165

Jason Chesney, Site 0059

Julie Brahmer, Site 0092

Donald Lawrence, Site 0039

David Reardon, Site 0082

Leslie Fecher, Site 0143

Thomas Amatruda, Site 0100

Lionel Lewis, Site 0014

Saby George, Site 0128

Lisa Roth, Site 0202

Ana Molina, Site 0185

Jennifer Atlas, Site 0204

April Salama, Site 0016

Patrick Ward, Site 0085

Asrar AlAhmadi, Site 0103

Suresh Nair, Site 0037

Melissa Wilson, Site 0054

Brian Lingerfelt, Site 0228

David Spigel, Site 0130

Site 0364

John Hyngstrom, Site 0055

Site 0124

Mark Albertini, Site 0065

Mirta Varela, Site 0199

Site 0030

Site 0349

Karen Briscoe, Site 0045

Site 0062

Site 0009

Andre van der Westhuizen, Site 0193

Howard Gurney, Site 0208

Site 0021

Site 0372

Site 0347

Site 0196

Site 0365

Benjamin Brady, Site 0005

Lukas Koch, Site 0254

Clemens Mayr, Site 0149

Christoph Hoeller, Site 0104

Matthias Pinter, Site 0321

Site 0329

Veerle Surmont, Site 0232

Bart Neyns, Site 0139

Site 0157

Site 0260

Site 0155

Site 0113

Site 0331

Site 0264

Site 0093

Site 0262

Site 0355

Andreia Cristina de Melo, Site 0266

Site 0258

Site 0302

Site 0340

Site 0111

Bristol-Myers Squibb

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Pan Tumor Rollover Study

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Exelixis

Novartis

Clovis Oncology, Inc.

Janssen Pharmaceuticals

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antibodies

Antibodies, Monoclonal

Paclitaxel

Albumin-Bound Paclitaxel

Immunoglobulins

Dacarbazine

Antibodies, Blocking

Choosing from 1 of the following (to be consistent with approved label and/or applicable local clinical guidelines):

* Nivolumab + relatlimab (as Opdualag)
* Anti-PD-1 monotherapy (nivolumab or pembrolizumab)
* Single-agent chemotherapy (dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel)

Genetically modified Herpes Simplex Type 1 Virus.

Vusolimogene Oderparepvec

Nivolumab: Anti-PD-1 Monoclonal antibody. Relatlimab: A lymphocyte activation gene-3 (LAG-3) blocking antibody.

A programmed death receptor-1 (PD-1)-blocking antibody indicated.

Dacarbazine, temozolomide, or paclitaxel/albumin-bound paclitaxel.

Single-agent chemotherapy

Clinical Trials at Replimune

Giuseppe Gullo, MD

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment

Time from the date of randomization to death due to any cause

The time from the date of randomization to the earliest date of the objective documentation of progressive disease (PD) per RECIST v1.1 or death due to any cause.

The proportion of randomized patients with best overall response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria.

Replimune Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Prostatic Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Head and Neck Neoplasms

Transitional Cell Carcinoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Approximately 12 subjects will accrue across 1-2 dose levels of XL092 following the "rolling 6" design.

The recommended dose from the dose-escalation stage may be further explored in tumor-specific cohorts.

XL092

360 mg IV infusion once every 3 weeks (q3w)

1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)

480 mg IV infusion once every 4 weeks (q4w)

IV administration of nivolumab + relatlimab

Exelixis Clinical Trials

Backup or International

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in subjects with advanced solid tumors.

In the Expansion Stage, the safety and efficacy of XL092 as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Dose-escalation followed by expansion phase with parallel assignment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pan Tumor Rollover Study	NCT03899155	Cancer	Nivolumab Ipilimumab Cabozantinib Trametinib Relatlimab Nivolumab + Rel... Capecitabine Bevacizumab Temozolomide Rucaparib Daratumumab Regorafinib Leucovorin Fluorouracil Oxaliplatin Enzalutamide Sunitinib Pemetrexed Pembrolizumab	18 Years -	Bristol-Myers Squibb
Pan Tumor Rollover Study	NCT03899155	Cancer	Nivolumab Ipilimumab Cabozantinib Trametinib Relatlimab Nivolumab + Rel... Capecitabine Bevacizumab Temozolomide Rucaparib Daratumumab Regorafinib Leucovorin Fluorouracil Oxaliplatin Enzalutamide Sunitinib Pemetrexed Pembrolizumab	18 Years -	Bristol-Myers Squibb
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)	NCT06264180	Advanced Melano...	Vusolimogene Od... Nivolumab Nivolumab + Rel... Pembrolizumab Single-agent ch...	12 Years -	Replimune Inc.
Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors	NCT05176483	Renal Cell Carc... Metastatic Cast... Urothelial Carc... Solid Tumor Hepatocellular ... Non-small Cell ... Colorectal Canc... Head and Neck S...	XL092 Nivolumab Ipilimumab Nivolumab Nivolumab Nivolumab + Rel...	18 Years -	Exelixis
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma	NCT04697576	Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Clinical Stage ... Metastatic Mela...	Ipilimumab Nivolumab Pembrolizumab Quadrivalent In... Resection Nivolumab + Rel...	18 Years - 99 Years	Ohio State University Comprehensive Cancer Center
Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma	NCT06295159	Melanoma Stage ... Melanoma Stage ... Advanced Melano... Melanoma	Nivolumab Nivolumab + Rel... Ipilimumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)	NCT06264180	Advanced Melano...	Vusolimogene Od... Nivolumab Nivolumab + Rel... Pembrolizumab Single-agent ch...	12 Years -	Replimune Inc.
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma	NCT05625399	Melanoma	Nivolumab + Rel... rHuPH20	12 Years -	Bristol-Myers Squibb

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