Immuno-Oncology Clinical Trials
At the forefront of new discoveries
Immunotherapy is transforming cancer care by harnessing the body’s own immune system to target tumors with greater precision. But advancing these therapies requires adapting quickly to the unique and often unpredictable demands of immunotherapy cancer clinical trials.
In this rapidly evolving field, our Immuno-Oncology teams possess deep expertise in advancing new approaches to precision oncology in solid tumors, and in working with cutting-edge therapies including combination immunotherapies and complex study designs across all phases of the clinical development-to-commercialization lifecycle.
A legacy of innovation
Our experts were early pioneers in immuno-oncology. Syneos Health® conducted the studies that led to the approval of the very first immune checkpoint inhibitor, and we continue to innovate new advances in the field, including groundbreaking studies of novel immunomodulators and combination treatments.
Over the past five years, Syneos Health has contributed to the development and commercialization of groundbreaking immuno-oncology therapies, including:
108
studies with checkpoint inhibitors (CPIs)
5
studies involving genetically modified organisms (GMOs)
137
studies including over 22,000 patients across various subtypes
Advancing clinical trial design in immuno-oncology
Immuno-oncology clinical trial design must match the complexity of the science. Trials increasingly rely on biomarker-driven patient selection and adaptive frameworks to evaluate multiple therapies or indications in parallel. These models accelerate discovery but demand operational expertise across tumor types, endpoints and regulatory pathways.
To meet these challenges, Syneos Health offers you:
- Expertise in complex study designs, including basket studies, platform trials and umbrella trials across all clinical development phases
- Innovative approaches to precision medicine, particularly in combination immunotherapies
- Focus on robust safety management and efficacy data in biomarker-selected populations
- Meaningful patient engagement to inform everything from protocol design and study endpoint identification to patient recruitment and retention strategies that ease the burden of trial participation
Breast cancer immunotherapy clinical trials
From early-stage studies to late-phase and post-marketing research, our expert teams support the full continuum of breast cancer clinical trial design and execution. We’ve helped advance therapies across breast cancer subtypes, geographies and study designs, enabling our customers to make a meaningful difference for patients around the world.
A leading genitourinary cancer CRO
Supported by more than 40 medical directors including dedicated genitourinary (GU) cancer specialists, in recent years we’ve led dozens of GU cancer trials across thousands of patients and global sites, including ovarian cancer immunotherapy clinical trials and clinical trials for prostate cancer. Our expertise includes trial design, site selection and reporting to help ensure quality and efficiency at every stage. Coupled with extensive commercial experience supporting top marketed GU therapies, we’re focused on partnering with purpose to advance GU cancer innovation from development through launch.
Why choose Syneos Health for your immuno-oncology clinical trials?
Therapeutic Expertise
- Proven track record in operationalizing immuno-oncology studies across diverse disease settings and tumor types, including personalized therapies
- Support from medical oncologists to ensure robust evaluation of efficacy and actionable data
Site Relationships and Data Confidence
- Strong relationships with key opinion leaders, investigators and sites
- Dedicated Research Science Liaisons to enhance engagement and enrollment
- Use of The Trusted Process® ensuring disciplined operations, quality risk management and actionable data generation
Real-World Evidence (RWE) Integration
- Use of RWE to support market access, payer activities and post-authorization commitments
- Expertise in planning and executing RWE strategies aligned with regulatory expectations
Focus on Patients
- In-depth insight collection from patients, families and advocacy communities to inform protocol design, patient recruitment and market access strategies
Let’s talk about your next immuno-oncology clinical trial.
Immune checkpoint inhibitors are cancer treatments that help the body’s immune system find and attack cancer cells. They work by blocking signals that stop immune cells from responding to tumors.
Immuno-oncology has transformed cancer care by harnessing the body’s own immune system to fight cancer more effectively. Unlike traditional treatments that target the tumor directly, immunotherapies like checkpoint inhibitors and CAR T-cell therapy help immune cells recognize and attack cancer. These therapies have led to longer-lasting responses and improved survival for some patients, even in advanced stages.
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