Clinical Studies for Immuno-Oncology Program (kidney/melanoma/cutaneous)

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Title: Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma (FORTUNE)
Brief Title: Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
Brief Summary: To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
For info regarding 25-158 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants with Solid Tumor Malignancies Known to Express B7-H7/HHLA2
Brief Title: A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2
Brief Summary: NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are: - what is an appropriate dose to be given to participants? - are the side effects of treatment manageable? - what is the preliminary anti-tumor activities? Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.
For info regarding 24-064 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1 Study with ABBV-CLS-484 Alone and in Combination in Subjects with Locally Advanced or Metastatic Tumors
Brief Title: Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Brief Summary: The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
For info regarding 23-138 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
Brief Title: Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care [SoC], best supportive care [BSC] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
For info regarding 22-500 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A PHASE 1A/1B STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF STK-012 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN SUBJECTS WITH SELECTED ADVANCED SOLID TUMORS
Brief Title: Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Brief Summary: This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.
For info regarding 22-173 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE
Brief Title: Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Brief Summary: This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel. Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.
For info regarding 21-072 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Defining the Treatment-free Interval (TFI) in Cancer Patients Receiving Nivolumab and Ipilimumab in Combination
Brief Title: Observational Study Protocol CA2099LY
For info regarding 20-066 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors -ARTISTRY-1
Brief Title: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors
Brief Summary: To better understand the safety and tolerability of ALKS 4230 in humans
For info regarding 16-229 please contact Immuno-Oncology Group Group Box BIDMC at Immuno-OncologyTrials@bidmc.harvard.edu
 
Title: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma (EA6141)
Brief Title: A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Brief Summary: This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
For info regarding 15-724 please contact Immuno-Oncology Group Group Box BIDMC at Immuno-OncologyTrials@bidmc.harvard.edu
 
Title: Extramammary Paget's Disease: A Review and Meta-Analysis
Brief Title: Extramammary Paget's Disease: A Review and Meta-Analysis
For info regarding 13-294 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Retrospective Database of Patients Seen in the Beth Israel Deaconess Medical Center Cutaneous Oncology Program
Brief Title: A Retrospective Database of Patients Seen in the Beth Israel Deaconess Medical Center Cutaneous Onco
For info regarding 12-335 please contact Immuno-Oncology Group Group Box BIDMC at Immuno-OncologyTrials@bidmc.harvard.edu
 
Title: PREDICTING OUTCOME OF RENAL CELL CARCINOMA PATIENTS BASED ON CLINICAL, MOLECULAR, RADIOLOGIC, AND HISTOLOGICAL CHARACTERISTICS
Brief Title: Predicting Outcome to Metastatic Renal Cell Carcin
For info regarding 07-336 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Collection of tissue and blood specimens and clinical data from patients with melanoma
Brief Title: MELANOMA SPECIMEN AND DATA COLLECTION
For info regarding 02-017 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Collection of Specimen and Clinical Data from Patients with Renal Cell Carcinoma
Brief Title: COLLECTION OF SPECIMENS FROM PATIENTS WITH RENAL CELL
For info regarding 01-130 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu