SHOMG Research Department offers a number of clinical trials to qualifying patients. Our current, actively enrolling clinical trials and studies are listed below.

For more information, please discuss your interest in participating in a clinical trial with your physician. You can also contact our office at (209)466-2626 and ask to be connected to the Research Department. Alternatively, email us at clinicaltrials@shomg.net with any questions regarding eligibility.

BREAST CANCER

Gilead Ascent-05 (GS-US-595-6184): A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Brief Summary: The goal of this study is to evaluate if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician’s choice (TPC), which includes either pembrolizumab alone or pembrolizumab plus capecitabine in participants with triple negative breast cancer who have residual disease after surgery and neoadjuvant therapy.

Natera SIGNAL-ER 101 (25-085-NCP): SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ / HER2- Breast Cancer

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as “Signatera Genome”) in participants with intermediate-risk HR+/HER2- early-stage breast cancer.
Based on ctDNA test results, participants will either start CDK4/6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment.

Personalis B-STRONGER-1: Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC – Phase I

Brief Summary: A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

ENROLLMENT ON HOLD UNTIL DECEMBER 2026

HEAD & NECK CANCER

GSK Jade 221530 (JADE Study): A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

Brief Summary: The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with locally advanced unresected head and neck squamous cell carcinoma (HNSCC).

p16 COHORT HAS MET CAP- CLOSE TO TOTAL ENROLLMENT CAP

LUNG CANCER

Mirati KRYSTAL-7: Phase 3 Trial of Adagrasib in Combination With Pembrolizumab in Patients With KRAS G12C Mutation

Brief Summary: The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

Pfizer C6461001: An Interventional Phase 3, Double-Blind, Randomized Study to Evaluate Efficacy and Safety of PF-8634404 in Combination With Chemotherapy Versus Pembrolizumab in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Brief Summary: This study evaluates whether Investigational Product (IP) PF-08634404 in combination with chemotherapy improves outcomes compared topembrolizumab plus chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.

BLADDER CANCER

Pfizer C5701009: A Phase 3, Open-label, Randomized Study to Evaluate Enfortumab Vedotin in Combination With Pembrolizumab in Participants With Muscle-Invasive Bladder Cancer Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Brief Summary: This study evaluates the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with muscle-invasive bladder cancer who are not undergoing cystectomy(bladder removal).

OBSERVATIONAL

Novartis ASC4REAL-2: A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy

Brief Summary: This registry collects real-world data on tolerability, safety, effectiveness, and patient-reported outcomes from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.

Paradigm Pan-Tumor MRD Study (PHPE-07-002): Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers

Brief Summary: This observational study collects clinical data, blood, and tumor samples from patients with early-stage solid tumors to support development of biomarkers for cancer detection and recurrence risk assessment.

BostonGene & Exigent Genomic INsight (BEGIN Study): A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting

Brief Summary: This study evaluates the clinical utility of comprehensive genomic profiling to identify actionable mutations and guide treatment decisions in patients with advanced cancers in the community setting.

Please see your treating physician for eligibility for any clinical trial we offer or you may contact our research department below.

Lenzi Cook, LVN
Clinical Research Coordinator
lcook@shomg.net

Julio Avalos, RN
Clinical Research Nurse Coordinator
julio@shomg.net

For additional department questions not related to eligibility or trials please contact:

Ashley Mussi McManus
Clinical Department Manager
amussi@shomg.net