Nigeria’s First Immunotherapy Clinical Trial Now Enrolling Patients with Colorectal Cancer

A first-of-its-kind clinical trial testing immunotherapy for colorectal cancer in Nigeria is now enrolling patients, following official approvals from the National Health Research Ethics Committee (NHREC) and the National Agency for Food and Drug Administration and Control (NAFDAC).

The Phase II study, “PD-1 (Programmed Cell Death Protein) Blockade in Mismatch-Repair Deficient Colorectal Cancer in Nigeria” will evaluate PD-1 blockade immunotherapy in patients with mismatch-repair deficient (dMMR) / microsatellite instability-high (MSI-H) colorectal cancer, a subtype that often does not respond well to standard chemotherapy.

Researchers say the trial is the first in sub-Saharan Africa to use immunotherapy for colorectal cancer and could help reshape treatment standards for patients in Nigeria.

Colorectal cancer is an increasing public health challenge in Nigeria, where less than half of patients survive one year after diagnosis. In addition, nearly 30% of Nigerian colorectal cancer patients have dMMR/MSI-H tumors, a genetic profile associated with poor response to traditional therapies. Studies in other countries have shown immunotherapy can be highly effective for these patients.

The trial is a global collaboration involving Obafemi Awolowo University (OAU), Lagos University Teaching Hospital (LUTH), Medserve, and Memorial Sloan Kettering Cancer Center (MSK) in the United States. Patients will be recruited and treated at OAU in Ile-Ife (Osun State), as well as LUTH and Medserve’s NSIA-Umuahia Diagnostic Centre in Lagos. MSK will serve as the study sponsor and data coordinating center.

BeOne Medicines will supply the immunotherapy drug tislelizumab, while BioVentures for Global Health will support regulatory approvals. The trial 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,” said Olusegun Isaac Alatise, co-principal investigator. “We are committed to ensuring the highest standards of research ethics and patient care throughout this study.”

“We are proud to be part of this groundbreaking trial that brings cutting-edge immunotherapy closer to Nigerian patients,” said Fatimah Abdulkareem, co-principal investigator at LUTH.

MSK’s Global Cancer Research and Training (GCRT) program, launched in 2011, has supported cancer research partnerships in Nigeria for more than a decade. MSK’s T. Peter Kingham, MD, said the team hopes the trial will “offer [patients] a greater chance for cure.”

The trial will follow strict ethical requirements, including ongoing safety monitoring, adverse event reporting, and annual compliance reviews.