RECENT ALLIANCE TRIAL ACTIVATIONS


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

Overview: This phase II Alliance trial studies 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.

Study Chair: Juneko Grilley-Olson, MD, University of North Carolina at Chapel Hill
E-mail: juneko_grilley-olson@med.unc.edu
Activated: 9/04/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A091902

Alliance A021806: A phase III trial of perioperative versus adjuvant chemotherapy for resectable pancreatic cancer

Overview: This phase III Alliance trial compares 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.

Study Chair: Cristina R. Ferrone, MD, Massachusetts General Hospital
E-mail: cferrone@mgh.harvard.edu
Activated: 7/01/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A021806

Alliance A081801: Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO

Overview: This phase III ALCHEMIST trial compares 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.

Study Chair: Jacob M Sands, MD, Dana-Farber Cancer Institute
E-mail: jacob_sands@dfci.harvard.edu
Activated: 6/03/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A081801

Alliance A221805: Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study

Overview: This phase II/III trial studies 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.

Study Chair: Ellen M. Lavoie Smith, PhD, RN, FAAN, University of Michigan
E-mail: ellenls@med.umich.edu
Activated: 5/01/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA221805

Alliance A151804: Establishment of a national biorepository to advance studies of immune-related adverse events

Overview: The purpose of this trial is to collect research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Study Chair: David Kozono, MD, PhD, Dana-Farber/Brigham and Women's Hospital
E-mail: dkozono@lroc.harvard.edu
Activated: 1/31/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA151804

Alliance A031803: Phase II trial of intravesical gemcitabine and MK-3475 (pembrolizumab) in the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer

Overview: This phase II trial studies how well gemcitabine together with pembrolizumab works in treating patients with non-muscle invasive bladder cancer who are unresponsive to the BCG vaccine. Drugs used in chemotherapy, such as gemcitabine, 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. 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. Adding pembrolizumab to gemcitabine may delay the return of bladder cancer for longer than gemcitabine alone.

Study Chair: Michael Woods, MD, Loyola University Medical Center
E-mail: michael.woods@lumc.edu
Activated: 1/06/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA031803

Alliance A031801: A phase II randomized trial of radium-223 dichloride and cabozantinib in patients with advanced renal cell carcinoma with bone metastasis (RadiCal)

Overview: This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcome in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.
Study Chair: Rana R McKay, MD, University of California San Diego
E-mail: rmckay@ucsd.edu
Activated: 12/13/19 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA031801

Alliance A071801: Phase III trial of post-surgical single fraction stereotactic radiosurgery (SRS) compared with fractionated SRS (FSRS) for resected metastatic brain disease

Overview:
This phase III trial looks to see how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Study Chair: Paul Brown, MD, Mayo Clinic
E-mail: brown.paul@mayo.edu
Activated: 10/11/19 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA071801

Alliance A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)

Overview:
This phase III trial looks at how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).

Study Chair: Kimmie Ng, MD, Dana-Farber Cancer Institute
E-mail: kng4@partners.org
Activated: 9/30/19 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA021703

Alliance A071701: Genomically-guided treatment trial in brain metastases

Overview:
This phase II Alliance trial looks at how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

Study chair: Priscilla Brastianos, MD, Massachusetts General Hospital
E-mail: pbrastianos@partners.org
Activated: 8/15/19 | Status: Now recruiting participants
Link: http://bit.ly/AllianceA071701

Alliance A051701: Randomized phase II/III study of venetoclax (ABT199) plus dose-adjusted EPOCH-R for MYC/BCL2 double-hit and double protein expressing lymphomas

Overview: This phase II/III Alliance trial looks at whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax, to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, 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 venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.

Study chair: Jeremy Abramson, MD, Massachusetts General Hospital Cancer Center
E-mail: jabramson@mgh.harvard.edu
Activated: 8/7/19 | Status: Now recruiting participants
Link: http://bit.ly/AllianceA051701

Alliance A221702: Axillary Reverse Mapping: A prospective trial to study rates of lymphedema and regional recurrence after sentinel lymph node biopsy and sentinel lymph node biopsy followed by axillary lymph node dissection with and without axillary reverse mapping (ARM)

Overview: This phase III Alliance trial looks at how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Study chair: V. Suzanne Klimberg, MD, PhD, University of Texas Medical Branch at Galveston
E-mail: Vsklimbe@utmb.edu
Activated: 5/31/19 | Status: Now recruiting participants
Link: http://bit.ly/AllianceA221702

Alliance A091802: Phase II randomized trial of avelumab plus cetuximab versus avelumab alone in advanced cutaneous squamous cell carcinoma of the skin (cSCC)

Overview: This phase II Alliance trial looks at how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Study chair: Dan P. Zandberg, MD, University of Pittsburgh Medical Center Hillman Cancer Center
E-mail: zandbergdp@upmc.edu
Activated: 5/17/19 | Status: Now recruiting participants
Link: http://bit.ly/AllianceA091802

Alliance A031704 - PD-inhibitor (nivolumab) and ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab: A phase III trial in metastatic untreated renal cell cancer (PDIGREE)

Overview: This phase III Alliance trial looks at how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. 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. Drugs used in chemotherapy, such as cabozantinib, 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. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

Study chair: Tian Zhang, MD - Duke University Medical Center
E-mail: tian.zhang2@dm.duke.edu
Activated: 5/9/19 | Status: Now recruiting participants
Link: http://bit.ly/AllianceA031704