ESITC LeAPs into Its Next 25 Years
Earlier in this 25th anniversary year for our Early Stage Investigator Training Course (ESITC), SWOG's leadership opened a conversation about how our flagship training program needed to evolve in a time when trials are growing increasingly complex.
Our discussion continues, and we’re moving toward significant changes to the course over the coming year, starting with a soft launch today of a new and more descriptive name for the program: the SWOG Leadership And Project Development Course – the SWOG LeAP-D Course, or Leap-D, for short (“You mentoring Leap-D this year?” “Yes, yes I am ….”)
My other big announcement is that we’ve recently selected the members of the program’s 28th cohort, a group that will meet face to face in a late September workshop in Seattle.
I’ve always maintained the ESITC (LeAP-D) can be a tool for predicting, and dare I say, creating SWOG’s future. In that September workshop, we’ll glimpse not only some of the trials we’re likely to activate in the next couple of years but also, potentially, the faces of some of our future committee chairs, executive officers, and maybe even group chairs.
We took a pandemic-induced break from the ESITC in 2022, but we came back strong in 2023 and 2024, and some of the trial concepts nurtured in those two workshops are now enrolling participants – or soon will be.
- Dr. Jonathan Sham, from our 2023 ESITC, recently saw the activation of the trial he refined in that course – the S2408 palliative care study testing whether a single dose of lanreotide can reduce the risk of postoperative pancreatic fistulae.
- His 2023 colleague, Dr. Rachael Safyan, is expecting an early-fall activation of the study she workshopped in Seattle, the S2433 phase III trial in pancreatic adenocarcinoma.
- And Dr. Pedro Barata, alumnus of last year’s ESITC, chairs the S2419 BioFront trial, on track for an early 2026 activation.
Below is the incoming class of 2025 early career investigators.
Jeremy Harris, MD, MPhil
Institution: University of California – Irvine
Committee: early therapeutics and rare cancers – sarcoma working group
Dr. Harris is developing the S2505 phase III trial, the concept for which was recently approved by the NCI’s Cancer Therapy Evaluation Program (CTEP). This randomized study in patients with high-risk resectable soft-tissue sarcomas will ask whether a shorter course of ultra-hypofractionated preoperative radiation is non-inferior to the standard preoperative radiation regimen.
Ghulam Rehman Mohyuddin, MD
Institution: University of Utah – Huntsman Cancer Institute
Committee: myeloma
Dr. Mohyuddin is at work on a trial concept that revisits the model of long-term maintenance therapy in myeloma. It asks whether patients with standard-risk myeloma who achieve minimal residual disease negativity (i.e., are MRD-negative) after induction therapy and autologous stem cell transplant can abbreviate their maintenance therapy. The trial will assess whether it’s safe for these patients to end maintenance therapy (with continued MRD monitoring) after six months.
Carolyn Moloney, MBBCh, MSc
Institution: Northwestern Memorial
Committee: lung
Dr. Moloney will work on the development of “MRD RESTART: A Minimal Residual Disease (MRD) Guided Approach to Intensifying Adjuvant or Consolidative Treatment in Stage IB-Ill Non-Small Cell Lung Cancer (NSCLC) - A Prospective Randomized Control Trial.” The study’s hypothesis is that we can use ultrasensitive measures of MRD from plasma to identify which patients with stage IB-III NSCLC will benefit from intensified adjuvant or consolidative immunotherapy or adjuvant targeted therapy.
Mamta Parikh, MD, MS
Institution: University of California – Davis Comprehensive Cancer Center
Committee: genitourinary – bladder
Dr. Parikh has proposed a phase III study titled “Neoadjuvant Pragmatic Trial in Urothelial/Bladder Cancer (NEPTUNE),” that would randomize patients to either of two new perioperative therapy regimens given in conjunction with radical cystectomy, with a goal of comparing two newly emerging standards of care. The study could identify differences in response to treatment by the bladder cancer’s molecular subtype.
Mariya Rozenblit, MD
Institution: Yale University
Committee: breast
Dr. Rozenblit has proposed a randomized phase III trial comparing standard of care systemic therapy to multimodality therapy in patients with HER2-positive de novo stage IV oligometastatic breast cancer. The trial will test the hypothesis that, for these patients, multimodality therapy that includes standard systemic therapy followed by surgical resection of the primary tumor and radiation therapy to all detectable metastatic sites will extend overall survival, as compared to standard of care systemic therapy.
Mark D. Tyson, MD, MPH
Institution: Mayo Clinic – Arizona
Committee: genitourinary – bladder
Dr. Tyson will develop his concept for the ASCEND trial, a randomized phase III study in patients with non-muscle invasive bladder cancer that would compare two intravesical regimens – a widely used chemotherapy regimen versus an investigational combination of chemo with immunotherapy. The proposal incorporates a pragmatic trial design with embedded quality-of-life assessments.
All of these proposals are great fits for the NCTN and, in spite of their high potential for patient benefit, are unlikely to be undertaken in another context – too large for a single institution or even a regional network, and with limited potential for specific financial return that would make them candidates for private industry sponsorship (although some will certainly be carried out in collaboration with industry partners).
But developing high-potential cancer trials and nurturing high-potential research leaders is what the course is all about – whether we call it YITC, ESITC, or LeAP-D. The start of its second quarter century is also a great opportunity to say thank you to The Hope Foundation for Cancer Research for its unflagging support of our flagship professional development program.
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