ALX148 + Chemotherapy + Immunotherapy for Ovarian Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that prior systemic anti-cancer therapy should not have been taken within 4 weeks before starting the trial, and certain immunosuppressive therapies are not allowed. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug ALX148 + Chemotherapy + Immunotherapy for ovarian cancer?
Research shows that pegylated liposomal doxorubicin (a form of doxorubicin) has shown a 26% response rate in ovarian cancer patients who did not respond to other treatments, indicating its potential effectiveness. Additionally, doxorubicin is known to be active in treating ovarian cancer, and its combination with other drugs is being explored to improve outcomes.12345
What safety data exists for ALX148, doxorubicin, and pembrolizumab in humans?
Doxorubicin, a chemotherapy drug, can cause side effects like myelosuppression (reduced blood cell production), cardiotoxicity (heart damage), and nausea. Liposomal formulations of doxorubicin may have fewer side effects, but still require careful monitoring for issues like hand-foot syndrome. Pembrolizumab, an immunotherapy, is generally well-tolerated but can cause immune-related side effects.26789
What makes the drug combination of ALX148, Doxorubicin, and Pembrolizumab unique for treating ovarian cancer?
This treatment combines ALX148, a novel agent, with Doxorubicin and Pembrolizumab, which are known for their roles in chemotherapy and immunotherapy, respectively. The unique aspect is the combination of these drugs, potentially enhancing the immune response against ovarian cancer while utilizing the targeted delivery and reduced toxicity profile of liposomal doxorubicin.34101112
What is the purpose of this trial?
Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).
Research Team
Alexander B. Olawaiye
Principal Investigator
UPMC Hillman Cancer Center
Eligibility Criteria
This trial is for women over 18 with recurrent epithelial ovarian cancer that's resistant to platinum-based therapy. They must have had fewer than six prior treatments, an ECOG performance status of 0-1, and measurable disease. Participants need normal organ/marrow function, known BRCA status, and agree to contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pegylated Liposomal Doxorubicin, pembrolizumab, and ALX148 every 21 days until disease progression or unacceptable toxicity
Maintenance Therapy
For patients with a complete response, maintenance therapy with pembrolizumab and ALX148 continues for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ALX148
- Doxorubicin
- Pembrolizumab
Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
Haider Mahdi
Lead Sponsor
Alexander B Olawaiye, MD
Lead Sponsor
ALX Oncology
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University