In an international oncology trial, effective communication, close collaboration, and meticulous oversight are key to agile site initiation and rapid enrollment.
SITUATION
Pivotal S.L.U. was selected by a U.S. biotechnology company conducting an international Phase 1/2 clinical trial of an innovative anti-PD-L1 antibody drug in patients with advanced cancers. The sponsor team was looking for an oncology-focused CRO capable of addressing the specific protocol’s requirements and expediting the start-up process to rapidly achieve quality enrollment milestones, facilitating the expansion into Western Europe of the cohort in locally advanced and metastatic cSCC.
Pivotal was selected to provide Regulatory, Clinical Operations, Medical Monitoring and Pharmacovigilance services to execute this challenging study in the EU region.
CHALLENGES
The sponsor was motivated to initiate and complete the study recruitment as quickly as possible. Challenges faced:
- Aggressive timelines: The study required an expedited regulatory strategy, rapid contract negotiations and tight deadlines for first site activation and first patient enrollment.
- Covid-19 restrictions: Site visits for PSVs, SIVs and first SMVs were impacted by the then ongoing pandemic-related restrictions.
- Specific protocol requirements: The study involved specifications, including drug storage and IV administration, multiple blood and tissue sample shipments to various central labs, and centralized imaging reviews. This required thorough, well-structured training tailored to the multidisciplinary teams at each site.
- Competitive market landscape: With several anti-PD-L1 drugs already available and several advanced research programs targeting similar indications, patients’ recruitment faced significant competitive pressures.
SOLUTION
Following the strong results from the escalation portion of the trial, both the sponsor and Pivotal were eager to move forward with enrollment for the cSCC expansion cohort to accelerate regulatory approval.
Pivotal worked very closely with the sponsor to ensure swift sites activation and enrollment. A strategic approach, fluid communication and seamless coordination were key to meeting the sponsor’s expectations. The process began with strategic alignment; a kick-off meeting and weekly status meetings focused on sites´ prioritization. A site-specific micromanagement approach was key to overcoming challenges and ensuring success.
STRATEGY
PIVOTAL IMPLEMENTED TARGETED STRATEGIES TO ACCELERATE ENROLLMENT:
- Pivotal´s EU Medical Monitor, in coordination with the sponsor, leveraged the excitement and interest around the available results from the escalation phase to motivate investigators and increase response times.
- Pivotal´s previous experience in other skin cancer trials paved the way for the opportunity to build a strong and fluid relationship with some of the key opinion leaders and sites streamlining start-up and initiation activities.
- Country-specific regulatory processes were carefully navigated through with tailored approaches to accelerate approvals.
- Customized site-specific training plans and tools ensured a deep understanding of study procedures optimizing site performance.
- Continuous communication with Country Coordinators and Principal Investigators fostered strong investigators´ commitment.
- The clinical operations team maintained very close follow-up with sites, resulting in a very low rate of significant deviations despite the trial’s complexity.
RESULTS
Through strong collaboration and seamless communication among all stakeholders, the study benefited from rapid decision-making and proactive issues´ resolution, minimizing delays and optimizing efficiency.
Pivotal met the sponsor’s expectations achieving several key milestones ahead of schedule, including last patient in (LPI).
KEY ACHIEVEMENTS:
- Spain and France were activated within 4 months of submission, despite the summer break.
- First patient in (FPI) was achieved within one month of site activation.
- 100% of the originally planned patients were enrolled within the expected timelines.
- Despite a later onboarding, Western Europe became the fastest-recruiting and second highest-enrolling region overall.
- Based on the promising results from this Phase I/2 clinical trial, the FDA approved the investigational drug in December 2024, with EMA filing expected in 2025.
MEDIA CONTACT
Ms. Natalia Farr
