RECENTLY ACTIVATED ALLIANCE TRIALS

Alliance A032102: PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Overview: This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing. 

Study Chair: Rana McKay, MD, University of California San Diego Health
Activated: 10/11/2024 | To learn more about Alliance A032102, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06632977

Alliance A072201: 
Randomized phase II trial of anti-lag-3 and anti-PD-1 blockade vs. SOC in patients with recurrent glioblastoma

Overview: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.

Study Chair: Michael Lim, MD, Stanford University School of Medicine
Activated: 09/3/2024 | To learn more about Alliance A072201, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06325683

Alliance A062101: A phase I/II study of the safety, tolerability and efficacy of belantamab mafodotin (GSK2857916) in combination with iberdomide (CC-220)/dexamethasone versus belantamab mafodotin (GSK2857916)/dexamethasone in relapsed refractory multiple myeloma

Overview: This phase I/II trial tests the safety, side effects, best dose, and effectiveness of iberdomide in combination with belantamab mafodotin and dexamethasone in treating patients with multiple myeloma (MM) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Multiple myeloma is a cancer that affects white blood cells called plasma cells, which are made in the bone marrow and are part of the immune system. Multiple myeloma cells have a protein on their surface called B-cell maturation antigen (BCMA) that allows the cancer cells to survive and grow. Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Belantamab mafodotin has been designed to attach to the BCMA protein, which may cause the myeloma cell to become damaged and die. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Iberdomide plus belantamab mafodotin may help slow or stop the growth of cancer in patients with multiple myeloma.

Study Chair: Monique A. Hartley-Brown, MD, MMSc, Dana-Farber Cancer Institute
Study Co-Chair: Yvonne Efebera, MD, MPH, Ohio Health
Activated: 08/30/2024 | To learn more about this trial, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06232044

Alliance A062102: Randomized phase 2 study of iberdomide maintenance therapy following idecaptagene vicleucel CAR-T in multiple myeloma patients

Overview: This phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel (a type of chimeric antigen receptor T-cell [CAR-T] therapy) for multiple myeloma. The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications. There is currently no medication approved specifically for use after idecabtagene vicleucel treatment. Upon administration, iberdomide modifies the immune system and activates immune cells called T-cells, which could enhance the effectiveness of idecabtagene vicleucel. Iberdomide may keep multiple myeloma under control for longer than the usual approach (disease monitoring) after idecabtagene vicleucel, and may help multiple myeloma patients live longer.

Study Chair: Sascha Tuchman, MD, UNC Lineberger Comprehensive Cancer Center
Activated: 04/4/2024 | To learn more about Alliance A062102, visit CT.gov or click here. 
ClinicalTrials.gov Identifier: NCT06179888