E-Newsletter - May 2021
Spotlight on Alliance Trials
 

Alliance ACTIVATES 11 NEW TRIALS OVER THE PAST YEAR

The Alliance has activated a clinical trial nearly every month over the past year through the COVID-19 pandemic, totally 11 new trials available in academic and community sites across the U.S. for patients with cancer.

Let’s take a look at these Alliance trials.

Alliance A031902 (CASPAR - A phase III trial of enzalutamide and rucaparib as a novel therapy in first-line metastatic castration-resistant prostate cancer) is being led by Arpit Rao, MD, of the University of Minnesota. This active randomized, placebo-controlled phase III Alliance trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient. 
ClinicalTrials.gov Identifier: NCT04455750

Alliance A011801 (The CompassHER2 trials (Comprehensive use of pathologic response assessment to optimize therapy in HER2-positive breast cancer) CompassHER2 residual disease (RD), a double-blinded, phase III randomized trial of T-DM1 compared with T-DM1 and tucatinib) is being led by Ciara C. O'Sullivan, MB, BCh, BAO, of the Mayo Clinic. This active phase III Alliance trial is studying how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
ClinicalTrials.gov Identifier: NCT04457596

Alliance A031901 (Duration of immune checkpoint therapy in locally advanced or metastatic urothelial carcinoma: A randomized phase 3 non-inferiority trial) is being led by Xiao X. Wei, MD, MAS, of the Dana-Farber Cancer Institute. This active phase III Alliance trial compares survival in patients with urothelial cancer who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.
ClinicalTrials.gov Identifier: NCT04637594

Alliance A191901 (Optimizing endocrine therapy through motivational interviewing and text interventions) is being led by Katherine E. Reeder-Hayes, MD, MBA, MSc, of the University of North Carolina at Chapel Hill. This active phase III Alliance trial is comparing an additional support program, using text message reminders and/or telephone-based counseling, with usual care in making sure patients with breast cancer take their endocrine therapy medication as prescribed. Poor medication adherence has been shown to be a serious barrier to effective treatment for patients with breast cancer that is hormone receptor-positive. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.
ClinicalTrials.gov Identifier: NCT04379570

Alliance A021804 (A prospective, multi-institutional phase II trial evaluating temozolomide vs. temozolomide and olaparib for advanced pheochromocytoma and paraganglioma) is being led by Jaydira Del Rivero, MD, of the National Cancer Institute, and Kimberly J. Perez, MD, of the Dana-Farber Cancer Institute. This active phase II Alliance trial is studying how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells cannot repair themselves, and they may stop growing. Drugs used in chemotherapy, such as 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. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.
ClinicalTrials.gov Identifier: NCT04394858

Alliance A071702 (A phase II study of checkpoint blockade immunotherapy in patients with somatically hypermutated recurrent glioblastoma) is being led by Gavin P Dunn, MD, of the Washington University School of Medicine in St. Louis. This active phase II Alliance trial is studying the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has recurred and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy).
ClinicalTrials.gov Identifier: NCT04145115

Alliance A171901 (Older non-small lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice)) is being led by Aminah Jatoi, MD, of the Mayo Clinic and Melisa L. Wong, MD, MAS, of the University of California San Francisco. This active Alliance trial is studying the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). 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. Drugs used in chemotherapy, such as pemetrexed and carboplatin, 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. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.
ClinicalTrials.gov Identifier: NCT04533451

Alliance A091902 (A multicenter phase II trial of paclitaxel with and without nivolumab in taxane naive, and nivolumab and cabozantinib in taxane pretreated subjects with angiosarcoma) is being led by Juneko Grilley-Olson, MD, of the University of North Carolina at Chapel Hill. This active phase II Alliance trial is studying how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to see if the combination of nivolumab and paclitaxel or cabozantinib can shrink soft tissue sarcoma and possibly prevent it from coming back.
CT.gov Link: http://bit.ly/Alliance-A091902

Alliance A021806 (A phase III trial of perioperative versus adjuvant chemotherapy for resectable pancreatic cancer) is being led by Cristina R. Ferrone, MD, of Massachusetts General Hospital. This active phase III Alliance trial is comparing perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery. Giving chemotherapy before and after surgery may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery.
ClinicalTrials.gov Identifier: NCT04339738

Alliance A081801 (Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO) is being led by Jacob M Sands, MD, of the Dana-Farber Cancer Institute. This active phase III ALCHEMIST trial is comparing the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. 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. The purpose of this trial is to find out if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for non-small cell lung cancer.
ClinicalTrials.gov Identifier: NCT04267848

Alliance A221805 (Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study) is being led by Ellen M. Lavoie Smith, PhD, RN, FAAN, of the University of Michigan. This active phase II/III trial is studying the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that helps relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
ClinicalTrials.gov Identifier: NCT04137107

 

 

 

For other articles in this issue of the Alliance E-News newsletter, see below.