First Clinical Trial Using Immunotherapy in Nigeria Now Enrolling Patients with Colorectal Cancer

ILE-IFE AND LAGOS, NIGERIA, and NEW YORK CITY, UNITED STATES - A ground-breaking clinical trial aimed at transforming treatment options for patients with colorectal cancer in Nigeria is actively enrolling patients after gaining official approval by the National Health Research Ethics Committee (NHREC) and the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria. The research, a global collaboration between experts from Obafemi Awolowo University (OAU), Lagos University Teaching Hospital (LUTH), and Medserve in Nigeria and Memorial Sloan Kettering Cancer Center (MSK), a global leader in cancer care based in the United States, will explore the use of a type of immunotherapy called PD-1 blockade in patients with mismatch-repair deficient (dMMR) colorectal cancer. The first clinical trial in sub-Saharan Africa to utilize immunotherapy, a treatment that uses a person's own immune system to fight cancer, researchers aim to change the standard of care for Nigerians living with colorectal cancer.

Colorectal cancer is a growing health problem in Nigeria, with less than half of Nigerian patients with colorectal cancer living one year after diagnosis. Furthermore, nearly 30 percent of all Nigerian patients with colorectal cancer have dMMR or microsatellite instability-high (MSI-H). This genetic mutation often does not respond to traditional treatment options, such as chemotherapy. Research in other countries has shown that immunotherapy is highly effective in colorectal patients with dMMR.

The Phase II study, titled "PD-1 (Programmed Cell Death Protein) Blockade in Mismatch-Repair Deficient Colorectal Cancer in Nigeria," has received full committee review and approval by the NHREC - the organization responsible for ensuring that all health research conducted in Nigeria is ethical and globally compliant - and by NAFDAC, the organization that regulates and controls the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents in Nigeria. Patients will be recruited and treated at OAU in Ile-Ife, Osun, Nigeria, and at LUTH and Medserve's NSIA-Umuahia Diagnostic Centre in Lagos, Nigeria. As the study sponsor and data coordinating center, investigators from MSK will work closely with teams from OAU, LUTH, and Medserve on the research. Additionally, BeOne Medicines will supply and distribute the immunotherapy drug tislelizumab, and BioVentures for Global Health will support the regulatory approvals in Nigeria. This study is partially funded by the Thompson Family Foundation.

"The approval of this trial marks an important milestone in the fight against colorectal cancer in Nigeria. Our research could provide vital insights into novel treatment strategies, particularly for patients with limited therapeutic options due to genetic mutations. We are committed to ensuring the highest standards of research ethics and patient care throughout this study," said Olusegun Isaac Alatise, co-principal investigator, Professor of Surgery at the Faculty of Clinical Sciences, College of Health Sciences at Obafemi Awolowo University, Consultant General Surgeon at the OAU Teaching Hospital, and National Director, African Research Group for Oncology.

"We are proud to be part of this groundbreaking trial that brings cutting-edge immunotherapy closer to Nigerian patients with colorectal cancer. This collaboration demonstrates our commitment to advancing cancer care and ensuring that our patients benefit from the very best of global research," said Fatimah Abdulkareem, co-principal investigator, and Professor of Anatomic & Molecular Pathology at the Faculty of Basic Clinical Sciences at the Lagos University Teaching Hospital.

MSK is one of the world's top comprehensive cancer centers. As part of MSK's vision to be the global authority on cancer, the institution launched the Global Cancer Research and Training (GCRT) program in 2011 to improve outcomes for people with cancer in low- and middle-income countries (LMIC), with a focus on collaborative research and training efforts in sub-Saharan Africa. Through the GCRT Program, MSK formed a partnership in 2013 with OAU Teaching Hospital, one of the foremost teaching hospitals in Nigeria, to establish the African Research Group for Oncology (ARGO), a National Cancer Institute (NCI)-recognized consortium to facilitate cancer research and training initiatives in Nigeria.

"This trial builds on a groundbreaking study conducted at MSK that significantly transformed treatment options for some patients with colorectal cancer," said T. Peter Kingham, MD, FACS, co-principal investigator, Hepatopancreatobiliary Surgeon and Director, Global Cancer Research and Training at MSK. "We hope that this pioneering trial will lead to a similar shift in treatment possibilities for Nigerian colorectal cancer patients, offering them a greater chance for cure."

"Aligning with organizations which share the same objectives, we are building a sustainable model of patient-centric care. At MedServe, we strive to achieve equitable cancer care in innovative ways including strategic partnerships that prioritize access, affordabilitty, and excellent patient care. Quality oncology care should not be a privilege; it must be the minimum standard irrespective of location." Dr. Tolulope Adewole, CEO of Medserve.

The trial will be conducted in strict adherence to all institutional guidelines and ethical standards, including continuous monitoring of patient safety and prompt reporting of any adverse events. The study's approval also emphasizes the importance of ensuring all informed consent forms carry the HREC-assigned number and approval dates, with regular annual reports to maintain approval throughout the trial's duration.

Support from the NHREC and the NAFDAC underscores Nigeria's commitment to advancing medical research and improving health outcomes for its citizens. This clinical trial is a crucial step toward addressing gaps in cancer treatment in the region and could pave the way for future cancer research across Africa.

CONTACT
Rebecca Williams
Memorial Sloan Kettering Cancer Center
[email protected]