RECENT ALLIANCE TRIAL ACTIVATIONS
Alliance A092105: Randomized phase 2 study of nivolumab and ipilimumab with or without cabozantinib in patients with advanced nasopharyngeal carcinoma that have progressed after platinum treatment and immunotherapy
Overview: This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.
Study Chair: Glenn J. Hanna, MD, Dana-Farber Cancer Institute
Activated: 09/18/2023 | CT.gov Link: https://bit.ly/Alliance-A092105
Alliance A052101: A randomized phase 3 trial of continuous vs. intermittent maintenance therapy with zanubrutinib as upfront treatment in older patients with mantle cell lymphoma
Overview: This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
Study Chair: Anne Beaven, MD, University of North Carolina Chapel Hill
Activated: 09/8/2023 | CT.gov Link: https://bit.ly/Alliance-A052101
Alliance EAY191-A6: A ComboMATCH Treatment Trial: FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations
Overview: This phase II ComboMATCH treatment trial that compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting). Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by killing tumor cells. Leucovorin may help the other drugs in the mFOLFOX6 chemotherapy regimen work better by making tumor cells more sensitive to the drugs. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps to stop or slow the spread of tumor cells. Giving binimetinib in combination with mFOLFOX6 chemotherapy may be effective in shrinking or stabilizing advanced biliary tract cancers in the 2nd line setting.
Study Chair: Ardaman Shergill, MD, University of Chicago Medicine
Activated: 8/11/2023 | CT.gov Link: https://bit.ly/cmatch-A6
Alliance A222101: An early phase and phase II clinical trial to evaluate ganglioside-monosialic acid (GM1) for preventing paclitaxel-associated neuropathy
Overview: This phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Exposure to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a condition of weakness, numbness, and pain from nerve damage (usually in the hands and feet). GM1 is a part of the body's natural system that insulates nerves and helps to protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer patients receiving treatment with paclitaxel.
Study Chair: Elizabeth Cathcart-Rake, MD, Mayo Clinic
Activated: 5/31/2023 | CT.gov Link: https://bit.ly/Alliance-A222101
Alliance A022004: Randomized trial of consolidation targeted adjuvant therapy with encorafenib and cetuximab versus usual care for patients with stage II/III BRAF V600E colon cancer
Overview: This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.
Study Chair: Rona Yaeger, MD, Memorial Sloan Kettering Cancer Center
Activated: 5/30/2023 | CT.gov Link: https://bit.ly/Alliance-A022004
Alliance A012103: OptimICE-pCR: De-escalation of therapy in early-stage TNBC patients who achieve pCR after neoadjuvant chemotherapy with checkpoint inhibitor therapy
Overview: The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.
Study Chair: Sara Tolaney, MD, Dana-Farber Cancer Institute
Activated: 5/10/2023 | CT.gov Link: https://bit.ly/Alliance-A012103
Alliance A092107: A randomized phase 2 trial with a safety lead-in to evaluate palbociclib versus palbociclib and cemiplimab for the treatment of advanced dedifferentiated liposarcoma
Overview: This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone.
Study Chair: Matthew Ingham, MD, Columbia University
Activated: 3/24/2023 | CT.gov Link: https://bit.ly/Alliance-A092107
Alliance A082101: Multimodality immunotherapy in sarcomatoid mesothelioma
Overview: This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
Study Chair: Aaron Mansfield, MD, Mayo Clinic
Activated: 3/14/2023 | CT.gov Link: https://bit.ly/Alliance-A082101
Alliance A042001: A randomized phase II study comparing inotuzumab plus chemotherapy versus standard chemotherapy in older adults with philadelphia-chromosome-negative b-cell acute lymphoblastic leukemia
Overview: This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.
Study Chair: Marlise R. Luskin, MD, MSCE, Dana-Farber Cancer Institute
Activated: 1/11/2023 | CT.gov Link: https://bit.ly/Alliance-A022102
Alliance A022102: A randomized phase III trial of mFOLFIRINOX +/- nivolumab vs. FOLFOX +/- nivolumab for first-line treatment of metastatic HER2-negative gastroesophageal adenocarcinoma
Overview: This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
Study Chair: Haeseong Park, MD, MPH, Dana-Farber Cancer Institute
Activated: 1/11/2023 | CT.gov Link: https://bit.ly/Alliance-A022102
Alliance A022101: A pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur)
Overview: This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
Study Chair: Eric D. Miller, MD, PhD, Ohio State University Comprehensive Cancer Center
Activated: 1/10/2023 | CT.gov Link: https://bit.ly/Alliance-A022101
Trials Activated in 2022
Alliance A092104: A randomized phase 2/3 study of olaparib plus temozolomide versus investigator’s choice for the treatment of patients with advanced uterine leiomyosarcoma after progression on prior chemotherapy
Overview: This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.
Study Chair: Matthew Ingham, MD, Columbia University
Activated: 12/9/2022 | CT.gov Link: https://bit.ly/Alliance-A092104
Alliance A022104: The Janus Rectal Cancer Trial: A randomized phase II trial testing the efficacy of triplet versus doublet chemotherapy to achieve clinical compolete response in patients with locally advanced rectal cancer
Overview: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
Study Chair: J. Joshua Smith, MD, Memorial Sloan Kettering Cancer Center
Activated: 11/9/2022 | CT.gov Link: https://bit.ly/Alliance-A022104
Alliance A212102: Blinded reference set for multicancer early detection blood tests
Overview: This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
Study Chair: Marie E. Wood, MD
Activated: 8/1/2022 | CT.gov Link: https://bit.ly/AllianceA212102
Alliance A032101: A phase 2 trial of ADT interruption in patients responding exceptionally to AR-pathway inhibitor in metastatic hormone-sensitive prostate cancer (mHSPC): A-DREAM
Overview: This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.
Study Chair: Atish Choudhury, MD, PhD, Dana-Farber Cancer Institute
Activated: 7/15/2022 | CT.gov Link: https://bit.ly/Alliance-A032101
Alliance A221803: Mepitel film for the reduction of radiation dermatitis in breast cancer patients undergoing post-mastectomy radiation therapy: A randomized phase III clinical trial
Overview: This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.
Study Chair: Kimberly Corbin, MD, Mayo Clinic
Activated: 6/15/2022 | CT.gov Link: https://bit.ly/AllianceA221803
Alliance A091903: A randomized phase II trial of adjuvant nivolumab with or without cabozantinib in patients with resected mucosal melanoma
Overview: This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.
Study Chair: Alexander Shoushtari, MD, Memorial Sloan Kettering Cancer Center
Activated: 6/1/2022 | CT.gov Link: https://bit.ly/Alliance-A091903
Alliance A022001: Phase II randomized, prospective trial of lutetium lu 177 dotatate PRRT versus capecitabine and temozolomide in well-differentiated pancreatic neuroendocrine tumors
Overview: This phase II compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.
Study Chair: Timothy J. Hobday, MD, of Mayo Clinic
Activated: 3/16/2022 | CT.gov Link: https://bit.ly/Alliance-A022001
Alliance A032001: MAIN-CAV: Phase III randomized trial of maintenance cabozantinib and avelumab vs maintenance avelumab after first-line platinum-based chemotherapy in patients with metastatic urothelial cancer
Overview: This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.
Study Chair: Shilpa Gupta, MD, Cleveland Clinic
Activated: 3/10/2022 | CT.gov Link: https://bit.ly/Alliance-A032001
Alliance A211801: BRCA-P: A randomized, double-blind, placebo-controlled, multi-center, international phase 3 study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germline mutation
Overview: This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.
Study Chair: Judy E. Garber, MD, MPH, Dana-Farber Cancer Institute
Activated: 2/23/2022 | CT.gov Link: https://bit.ly/Alliance-A211801
