BASECAMP-1 screening study: a model for efficient enrolment in precision oncology clinical trials

Area of Science:

• Oncology
• Genomics
• Clinical Trials

Background:

• Identifying patients for precision oncology, especially rare molecular subtypes, is a significant challenge.
• Human leucocyte antigen (HLA)-A loss of heterozygosity (LOH) is a key eligibility criterion for certain advanced solid malignancy therapies.
• A master screening study, BASECAMP-1 (NCT04981119), was developed to address these recruitment challenges.

Purpose of the Study:

• To describe the BASECAMP-1 study design and its objectives.
• To compare the efficiency of traditional screening methods versus a novel bioinformatic approach for identifying eligible patients.
• To discuss the broader advantages of the BASECAMP-1 screening study.

Main Methods:

• Two patient identification strategies were employed: traditional screening and a co-developed bioinformatic program, Tempus Aware.
• Tempus Aware utilizes a clinico-genomic database with linked genomic, transcriptomic, and clinical data from routine care.
• Patients were screened for advanced solid malignancy and germline HLA-A*02 heterozygosity with tumor-associated HLA-A LOH.

Main Results:

• The Tempus Aware approach identified eligible patients more efficiently (1.8 participants/month) compared to the traditional method (0.7 participants/month).
• The bioinformatic approach leveraged existing clinical tumor sequencing, reducing resource use and study staff burden.
• Enrollment increased from 30 patients using the traditional method over 42 months to 55 patients using Tempus Aware over the last 30 months.

Conclusions:

• Clinico-genomic screening, as demonstrated by BASECAMP-1, offers a more efficient method for patient identification in precision oncology.
• The use of bioinformatic tools integrated with routine clinical data streamlines patient selection.
• Collaborative data-sharing can further enhance precision oncology initiatives.