Peering into SWOG's Future: Our ESITC

The ESITC is SWOG’s flagship career development program for our clinical trialists in the early years of their careers. Established in 1999, with the first associated workshop held in March of 2000, the program has graduated more than 120 investigators, including a number affiliated with our member sites in Latin America. It has generated dozens of SWOG trials and numerous SWOG leaders, including a notable fraction of our current senior leadership team. 

 The course is an intensive how-to in developing and conducting a SWOG clinical trial, with in-depth sessions on the details of protocol development, trial management, statistical analysis, and more. It features one-on-one mentoring by a senior SWOG leader. 

Here’s the list of those selected for this year’s ESITC, with their institutions, sponsoring research committees, and project topics. 

Pedro Barata, MD
Institution: University Hospitals Seidman Cancer Center 
Committee: genitourinary cancers
Dr. Barata is developing a phase III double-blinded trial (S2419, the BioFront Trial) that couples immune-based therapy with a live biotherapeutic (CBM588) or a placebo for front-line therapy in patients with advanced clear-cell renal cell carcinoma. He was awarded a Coltman Fellowship in 2023 to support his work on this concept.

Iván Lyra, MD 
Institution: Hospital de Clinicas Dr. Manuel Quintela, Uruguay
Committee: gastrointestinal cancers
Dr. Lyra’s project will test whether mFOLFOX6 as an alternative to modified FLOT4 can provide non-inferior recurrence-free survival but with a more favorable toxicity profile, in frail and older patients with resectable gastric cancer. The next issue of our SWOG Latin America Initiative (SLAI) newsletter – coming out soon – includes interesting background on this project (our first GI cancer project with SLAI) and on Dr. Lyra, along with a profile of SWOG’s member site in Uruguay. Watch your inbox!

Zin Myint, MD
Institution: University of Kentucky Markey Comprehensive Cancer Center
Committee: genitourinary cancers
Dr. Myint, SWOG’s institutional principal investigator for the University of Kentucky Medical Center, is designing a phase 2 study of neoadjuvant PD-1 blockade to learn whether it can be more effective and less toxic than current treatments in patients who have mismatch repair-deficient, localized high-grade upper tract urothelial carcinoma.

Izumi Okado, PhD
Institution: University of Hawaii Cancer Center
Committee: cancer care delivery
Rural cancer patients face unique barriers to clinical trial participation. Dr. Okado’s project will test whether a multilevel intervention – CTNow-Telehealth Support – which combines telehealth navigation and clinical trials education supported by a regional clinical trials hub can enhance trial access and facilitate referrals for rural patients with breast, lung, or gastrointestinal cancers.

Ali Zahalka, MD, PhD 
Institution: University of Texas Southwest Medical Center
Committee: genitourinary cancers
A Society of Urologic Oncology Fellow, Dr. Zahalka is designing a phase 1b dose-range finding study in patients with high-risk prostate cancer to determine whether long-acting peri-prostatic neuraxial inhibition before prostatectomy can decrease prostate cancer aggressiveness and delay disease progression or recurrence.

I’m grateful for all the reviewers and those who have agreed to take part as mentors to the above researchers in this year’s course, and for the efforts of the workshop’s presenters and organizers. Your work is building SWOG’s future – our future clinical trialists, our future studies, our future leadership cadre.

I’m also grateful for the financial and organizational support of The Hope Foundation for Cancer Research, which has made this course possible for almost 25 years now.

I want to highlight one other Hope Foundation career development award as well – we’ve just announced our latest John Crowley Award. Meant to promote statistical excellence in clinical trials, and honoring a man who served as SWOG group statistician for almost 30 years, this award provides a valuable opportunity for an early- to mid-career clinical trialist to collaborate with SWOG’s statistical faculty and data management staff through a brief in-person residency in Seattle.  

The newest recipient of the Crowley Award is Subodh Selukar, PhD, a clinical trial statistician with St. Jude Children’s Research Hospital who also works with the Children’s Oncology Group’s central nervous system disease committee. Dr. Selukar has proposed a project titled “Toward cure models for clinical trials: applications to small-sample oncology trials with rare events.” 

There’s no better way to get excited about SWOG’s future than to see our early-stage investigators engaging with the group. In September I’ll get to spend a few days in Seattle doing just that. It’s certainly a trip I’m looking forward to!

___________________________________________________

Trial of the Week

S2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases 

Brain metastases are a significant concern in patients with breast cancer. S2007 is testing a systemic therapy in those with HER2-negative invasive breast cancer and brain involvement. 

Patients are treated with the antibody–drug conjugate sacituzumab govitecan. Its payload is an active metabolite of irinotecan that crosses the blood–brain barrier. 

The trial’s primary endpoint is intracranial objective response rate, but the study is also tracking progression-free survival, overall survival, and the drug’s safety and tolerability. It will compare overall response rate across hormone-receptor subgroups (HR+ vs HR-) as well.

Activated at the end of 2020, S2007 has enrolled 24 patients toward its goal of 44 accruals, and 182 sites are approved to enroll to the trial. The Mayo Clinic and the Dana Farber Cancer Institute are the accrual leaders. 

The trial is led by Dr. Andrew Brenner, of The Mays Cancer Center at UT Health San Antonio, and Dr. Virginia Kaklamani, of UT Health San Antonio and the MD Anderson Cancer Center. 

Learn more about S2007 on the SWOG S2007 page or the CTSU S2007 page, which includes a link to a recording of an S2007 informational webinar.