Overcoming Challenges in Immuno-Oncology Clinical Research
Immuno-Oncology is moving at an accelerated pace with new approaches to harness the immune system to treat diseases. In this fast-paced field, awareness of the complex challenges and considerations – including operational considerations, biomarkers, safety testing, and imaging needs – is critical for the successful conduct of clinical trials for new agents. Accelerate your path to approval and set your trial up for success with guidance from the experienced, specialized team of Immuno-Oncology experts at Medpace.
Making the Complex Seamless® in
Global Immuno-Oncology Clinical Development
Clinical trials of immunotherapeutic agents have different considerations for successful execution than standard anti-cancer agents. As novel targets and methods of delivery are identified, investigators need to be aware of the effects on the immune system, including both immunosuppression and autoimmunity, especially as combination therapies are studied. Immunotherapeutic trials have distinctive issues to be addressed regarding patient selection, pharmacokinetics, trial monitoring, toxicity grading, and response assessment. Our cross-functional team of oncology-focused experts have the experience to guide sponsors through these complexities and set their trials up for success.
Immuno-Oncology CRO Capabilities
Medpace is a global, full-service CRO with a therapeutic focus in Hematology/Oncology and extensive Immuno-Oncology experience.
- Accomplished in-house I-O medical, operational, regulatory, and safety experts
- Knowledgeable in I-O study designs including umbrella studies, basket studies, modality, organ-based, and complex statistical designs such as m-TPI, m-TPI-2, and Bayesian
- Skilled in combination therapy research
- Adept in complex studies with Advanced Therapy Medicinal Products (ATMPs)
- Fully-integrated global Central Lab with extensive experience working with I-O biomarkers
- Experienced Imaging Core Lab with skilled in RECIST, irRC, irRECIST, and iRECIST
Immuno-Oncology Central Laboratory Capabilities
Immuno-Oncology biomarkers seek to characterize the relationship between the immune system, the tumor and its microenvironment, and the host. Unique interactions of these factors, as well as I-O biomarker presence and prevalence, contributes to the balance of activation versus suppression of the antitumor immune response.
Medpace Central Labs has extensive experience working with I-O biomarkers that address the interplay between the immune system and the tumor in four key areas including:
- Tumor antigens
- Inflamed tumor markers
- Immune suppression markers
- Host environment factors
Imaging Core Laboratory Capabilities
In most oncology clinical trials, tumor response occurs between 8 and 12 weeks. With immuno-oncology agents, however, tumor response may be delayed, and pseudo-progression has been described. This may provide a false assessment of a progressive disease. Newer radiographic staging systems have been developed for solid tumors and lymphomas.
Medpace Imaging Core Labs is experienced in many modalities and measurement criterion for critical imaging end-points in I-O trials including:
- Response evaluation criteria in solid tumors (RECIST), irRC, irRECIST, and iRECIST
- Nuclear medicine imaging including PERCIST and Lugano
- Database optimization for imaging endpoints in I-O trials including EDC and eCRF
Considerations for Managing Immuno-oncology Studies
Special Considerations for Managing Immuno-oncology Studies – A New Paradigm