Clinical Studies for Immunotherapy (Biologic Therapy)

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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 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 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications
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 phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.
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: 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