S2013 and S1501 Reopen for Enrollment with Key Protocol Updates

Two pivotal SWOG NCORP Research Base trials, S2013 (I-CHECKIT) and S1501, have reopened for enrollment after temporary closures earlier this year.

With some protocol updates and revisions, these trials are once again enrolling participants and moving forward with key objectives in the areas of immune-related adverse events (irAEs) and cancer treatment cardiotoxicity.

Here’s a quick update on both studies:

S2013 (I-CHECKIT) Trial: New Cohort Open for Enrollment

S2013, an observational study designed to develop and validate a model for predicting grade 3+ immune-related adverse events in patients undergoing immune checkpoint inhibitor (ICI)-based therapy, has reopened following a closure earlier this year after meeting its Cohort 1 accrual target. Cohort 1, which enrolled patients with solid tumors receiving ICI monotherapy, is now closed, and the study has launched Cohort 2, which will focus on patients about to begin therapy with ICI plus chemotherapy.

The revised study protocol includes several key updates:

Cohort 2 will enroll patients with lung cancer, triple-negative breast cancer, or gastroesophageal cancer, with a goal of enrolling 1,547 participants.

The study now includes an additional objective: exploring the association between dietary fiber intake and severe irAEs from ICI-based therapy.

Participants will complete a Dietary Screener Questionnaire at registration and again at four weeks.

Several requirements from Cohort 1, such as the Feasibility Questionnaire and tissue submission for banking, have been removed, simplifying the protocol and reducing the burden on sites and participants.

Important: Only NCORP and Minority/Underserved NCORP sites are eligible to enroll participants for Cohort 2. NCTN sites can no longer enroll, although they will continue to follow up with participants already enrolled in Cohort 1.

S2013 is co-led by  Krishna Gunturu and Dawn Hershman.

S1501: Redesigned and Open for Enrollment in Arm 3

S1501, a study on cardiotoxicity in cancer treatment, has undergone a major redesign after an interim analysis revealed that the event rate did not support the randomized intervention approach. The study has now shifted to an observational design to evaluate the incidence of cardiac dysfunction and develop a predictive model for patients taking trastuzumab for HER2-positive breast cancer.

Key updates for S1501:

Arm 1 (carvedilol intervention) and Arm 2 (no prophylaxis) are now closed to new accrual. Patients already enrolled in these arms can continue their protocol-specified therapy.

Arm 3 (non-randomized observation) has reopened, aiming to enroll 180 more participants to reach an accrual goal of 336. This arm focuses on patients taking beta blockers, ARBs, or ACE inhibitors.

The redesigned study has streamlined data collection processes, removing the need for real-time echocardiogram reads, making it easier for sites to administer.

This redesign is expected to accelerate the study’s completion while still yielding important insights into cardiotoxicity risks and treatment.

With these updates, both S2013 and S1501 are once again enrolling participants, advancing our understanding of adverse event risks in cancer treatment.