RECENTLY ACTIVATED ALLIANCE TRIALS

Alliance A012301: LoTam: A randomized, phase III clinical trial of low‐dose tamoxifen for selected patients with molecular low-risk early‐stage breast cancer

Overview: This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
Study Chair: Dean Shumway, MD, Mayo Clinic
Activated: 2/5/2025 | To learn more about LoTam, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06671912

Alliance A032201: Short term intensified pembrolizumab (KEytruda) and tivozanib for high-risk renal cell carcinoma - STRIKE

Overview: This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). 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. Tivozanib 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 stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Study Chair: Bradley McGregor, MD, Dana-Farber Cancer Institute
Activated: 2/5/2025 | To learn more about STRIKE, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06661720

Perioperative versus adjuvant systemic therapy in patients with resectable non-small cell lung cancer - PROSPECT LUNG (CTIU2317-A082304-S2402)

Overview: This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician.
Study Co-Chair: Daniel Morgensztern, MD, Washington University, Siteman Cancer Center
Study Co-Chair: Raid Aljumaily, MD, University of Oklahoma, OU Health Stephenson Cancer Center
Activated: 12/11/2024 | To learn more about PROSPECT-Lung, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06632327

Alliance A092205: Randomized phase III trial of pembrolizumab vs. pembrolizumab/cetuximab in recurrent or metastatic head and neck squamous cell carcinoma with platinum refractory disease

Overview: This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Study Chair: Siddharth Sheth, DO, MPH, UNC Lineberger Comprehensive Cancer Center
Activated: 11/21/2024 | To learn more about Alliance A092205, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06589804

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

Overview: This phase II trial biomarker selected study utilizes DNA alterations and RNA signature to allocate patients to treatment. 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 chemotherapy. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel chemotherapy injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. For patients without DNA alterations they will be allocated to the standard of care arm consisting of treatment with either abiraterone, enzalutamide, cabazitaxel or lutetium vipivotide tetraxetan. 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
Study Co-Chair: Himisha Beltran, MD, Dana-Farber Cancer Institute
Activated: 10/11/2024 | To learn more about Alliance A032102, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06632977