RECENT ALLIANCE TRIAL ACTIVATIONS

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 | CT.gov Link: https://bit.ly/Alliance-A062102

Alliance A022106: Phase II/III second-line NABPLAGEM vs. nab-paclitaxel/gemcitabine in BRCA1/2 or PALB2 mutant metastatic pancreatic ductal adenocarcinoma (PLATINUM)
Overview: This phase II/III trial compares the effect of the combination of nab-paclitaxel plus cisplatin and gemcitabine versus (vs.) nab-paclitaxel plus gemcitabine for the treatment of pancreatic cancer that has spread from where it first started (primary site) to other places in the body (metastatic) with genetic mutations in the BRCA1 or BRCA2 or PALB2 genes. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Giving nab-paclitaxel in combination with cisplatin and gemcitabine may work better than nab-paclitaxel plus gemcitabine for the treatment of metastatic pancreatic cancer.

Study Chair: Andrew H. Ko, MD, UCSF Helen Diller Family Comprehensive Cancer Center
Activated: 12/1/2023 | CT.gov Link: https://bit.ly/Alliance-A022106

Alliance EAY191-A3: Palbociclib and Binimetinib in RAS-Mutant Cancers
Overview: This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.

Study Chair: Geoffrey I Shapiro, MD, PhD, Dana-Farber Cancer Institute
Activated: 11/15/2023 | CT.gov Link: https://bit.ly/cmatch-A3