Master Protocols and Adaptive Trial Designs to Develop Tumor-Agnostic Drugs for Children: Essential Tools in the Era of the Research to Accelerate Cure and Equity Act. Off-Label Drug Use. Combination immunotherapy. Find out more about the study here. a phase 1/1b multicenter study to evaluate the humanized anti-cd73 antibody, cpi-006, as a single agent or in combination with ciforadenant, with pembrolizumab, and with ciforadenant plus pembrolizumab in adult subjects with advanced cancers (cpi-006-001) SAR441000 (BNT131) is being studied in a Phase 1 basket clinical trial as a monotherapy in patients with advanced melanoma and in combination with an anti-PD-1/PD-L1 checkpoint inhibitor in patients with advanced melanoma and certain solid tumors. Pembrolizumab is a type of immunotherapy, a drug that works by releasing the brakes on the immune system. a phase 1/1b multicenter study to evaluate the humanized anti-cd73 antibody, cpi-006, as a single agent or in combination with ciforadenant, with pembrolizumab, and with ciforadenant plus pembrolizumab in adult subjects with advanced cancers (cpi-006-001) Off-Label Drug Use. PURPOSE KEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types. BNT211 – A first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T cells as … Background Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populations or that allow adding/removing arms during the trial), offering enhanced efficiency and a more ethical approach to trial evaluation. Despite the many advantages of … Drugs Approved for Childhood Cancers. Deciding to Take Part in a Trial. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. Pembrolizumab was the first drug to be approved with a tumor-agnostic indication. Deciding to Take Part in a Trial. About the Associate Director. A … In the early-stage trial, Intellia's groundbreaking gene-editing therapy performed even better than expected, and it didn't seem to have a burdensome side-effect profile, either. Drugs Approved for Childhood Cancers. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. GPS IN COMBINATION WITH KEYTRUDA® (PEMBROLIZUMAB) BASKET STUDY (5 INDICATIONS) PHASE 2 TRIAL IN MULTIPLE INDICATIONS. Drugs Approved for Different Types of Cancer. About the Associate Director. A to Z List of Cancer Drugs. QPex Biopharma initiated a Phase I trial of QPX9003 for drug-resistant gram-negative infections. Meg Mooney, MD, MS, is the CTEP Associate Director where she has oversight and coordination responsibilities for the programmatic, financial, and administrative functions for the entire CTEP program, which covers a broad, multidisciplinary, clinical research effort to coordinate nationwide phase 1-3 clinical trials programs testing new treatment approaches for cancer. The three-arm Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess the combination of maveropepimut-S and KEYTRUDA ® with or without CPA. Selected NCI-Supported Trials. ... One report described evaluation of vibostolimab as either monotherapy or in combination with pembrolizumab ... multicenter, phase 1/2 basket study (NCT04761198) in patients with advanced solid tumors. Drugs Approved for Childhood Cancers. Despite the many advantages of … Published online: June 25, 2021 Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma Moskowitz et al. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. There are several other immunotherapy options being used or in development. We present interim results from patients with previously treated advanced cervical cancer. Pembrolizumab was the first drug to be approved with a tumor-agnostic indication. The results will be analyzed Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma Moskowitz et al. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. GPS IN COMBINATION WITH KEYTRUDA® (PEMBROLIZUMAB) BASKET STUDY (5 INDICATIONS) PHASE 2 TRIAL IN MULTIPLE INDICATIONS. In the early-stage trial, Intellia's groundbreaking gene-editing therapy performed even better than expected, and it didn't seem to have a burdensome side-effect profile, either. Selected NCI-Supported Trials. Questions to Ask about Treatment Clinical Trials. Taletrectinib is a next-generation TKI designed to target ROS1 and NTRK fusion mutations. A to Z List of Cancer Drugs. A to Z List of Cancer Drugs. Drugs Approved for Conditions Related to Cancer. Selected NCI-Supported Trials. Pembrolizumab, developed by Merck is approved for previously treated metastatic melanoma. Innovent Biologics dosed the first patient in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusion. The trial is expected to enroll 560 patients, with primary outcomes of PFS and overall survival (OS). Questions to Ask about Treatment Clinical Trials. Author Affiliations Article Information. Meg Mooney, MD, MS, is the CTEP Associate Director where she has oversight and coordination responsibilities for the programmatic, financial, and administrative functions for the entire CTEP program, which covers a broad, multidisciplinary, clinical research effort to coordinate nationwide phase 1-3 clinical trials programs testing new treatment approaches for cancer. Master Protocols and Adaptive Trial Designs to Develop Tumor-Agnostic Drugs for Children: Essential Tools in the Era of the Research to Accelerate Cure and Equity Act. Published online: June 25, 2021 A to Z List of Cancer Drugs. BNT211 – A first-in-human Phase 1/2a open-label, multi-center dose escalation and dose expansion basket trial of BNT211 with Claudin-6 CAR-T cells as … Selected NCI-Supported Trials. Purpose: KEYNOTE-158 ( ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types.We present interim results from patients with previously treated advanced cervical cancer. Drugs Approved for Different Types of Cancer. Pembrolizumab, developed by Merck is approved for previously treated metastatic melanoma. Drugs Approved for Different Types of Cancer. Drugs Approved for Childhood Cancers. Andrea Arfè, PhD 1; Lewis B. Silverman, MD 2; Florence Bourgeois, MD, MPH 3,4. Questions to Ask about Treatment Clinical Trials. pembrolizumab, and two Trk inhibitors, larotrectinib and entrectinib, underwent tissue- ... trial, the basket trial would be composed of sub-trial 1 with NSCLC, sub-trial 2 with ALCL, and sub-trial 3 with IMT, all with ALK fusion-positive tumors. Author Affiliations Article Information. QPex Biopharma initiated a Phase I trial of QPX9003 for drug-resistant gram-negative infections. Deciding to Take Part in a Trial. Drugs Approved for Different Types of Cancer. Off-Label Drug Use. The three-arm Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess the combination of maveropepimut-S and KEYTRUDA ® with or without CPA. Drugs Approved for Conditions Related to Cancer. The trial is expected to enroll 560 patients, with primary outcomes of PFS and overall survival (OS). Pembrolizumab is a type of immunotherapy, a drug that works by releasing the brakes on the immune system. Questions to Ask about Treatment Clinical Trials. Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. Combination immunotherapy. SAR441000 (BNT131) is being studied in a Phase 1 basket clinical trial as a monotherapy in patients with advanced melanoma and in combination with an anti-PD-1/PD-L1 checkpoint inhibitor in patients with advanced melanoma and certain solid tumors. Off-Label Drug Use. The results will be analyzed We present interim results from patients with previously treated advanced cervical cancer. PURPOSE KEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types. Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. Drugs Approved for Conditions Related to Cancer. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Purpose: KEYNOTE-158 ( ClinicalTrials.gov identifier: NCT02628067) is a phase II basket study investigating the antitumor activity and safety of pembrolizumab in multiple cancer types.We present interim results from patients with previously treated advanced cervical cancer. A … Taletrectinib is a next-generation TKI designed to target ROS1 and NTRK fusion mutations. Andrea Arfè, PhD 1; Lewis B. Silverman, MD 2; Florence Bourgeois, MD, MPH 3,4. Background Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populations or that allow adding/removing arms during the trial), offering enhanced efficiency and a more ethical approach to trial evaluation. In October 2017, SELLAS entered into a Clinical Trial Collaboration and Supply Agreement for the conduct of a combination clinical trial targeting multiple cancer types with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada). ... One report described evaluation of vibostolimab as either monotherapy or in combination with pembrolizumab ... multicenter, phase 1/2 basket study (NCT04761198) in patients with advanced solid tumors. Innovent Biologics dosed the first patient in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusion. In October 2017, SELLAS entered into a Clinical Trial Collaboration and Supply Agreement for the conduct of a combination clinical trial targeting multiple cancer types with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada). A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. 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