How to Overcome Challenges in Combination Immunotherapy Clinical Trials

Immunotherapy has quickly become a major focus in the world of cancer research and treatment. In recent years, there has been a surge in the number of biotech companies conducting clinical trials for combination immunotherapies.  

What are Combination Immunotherapies? 

The combination immunotherapy approach involves the use of two or more different types of immunotherapies in order to enhance the immune system’s response to cancer cells. This can include the use of standard of care immune checkpoint inhibitors, such as PD-1 inhibitors, along with novel biotechnology drugs that target specific immune pathways.  

The use of combination immunotherapies in cancer clinical trials has gained significant attention in recent years, as they have shown promising results in treating various types of cancer. Combination immunotherapy has the potential to offer significant benefits to patients. By targeting multiple pathways in the immune system, these therapies can enhance the body's natural defenses against cancer and improve response rates. 

However, in order to realize this therapy’s full potential, it is essential to overcome the obstacles that currently prevent the widespread adoption of combination immunotherapies in clinical trials. 

Challenges for Combination Immunotherapy Clinical Trials 

Conducting clinical trials for combination immunotherapies must solve for some unique challenges. 

Saturated Market Potential 

The main challenge is the high number of biotech companies that are interested in combining their study drug with standard of care immune checkpoint inhibitors. This influx of companies can lead to a saturation of the market, making it difficult for individual trials to stand out and gain the attention of investors and potential participants. Additionally, the sheer number of combination immunotherapy clinical trials can make it difficult for researchers to adequately compare and contrast the effectiveness of different combinations. 

Concern Around Immune-Related Adverse Events 

Furthermore, the potential for immune-related adverse events can be a concern with combination immunotherapies. These drugs are designed to enhance the immune system’s response to cancer cells, but this can also result in the immune system attacking healthy tissues in the body. While immune checkpoint inhibitors have shown to be relatively well-tolerated, adding additional drugs to the mix can increase the likelihood of adverse reactions. It can be difficult to determine which specific drug is causing any negative side effects, leading to challenges in optimizing dosing and treatment regimens. 

Difficulty in Design and Execution 

Finally, the complexity of these studies can make them difficult to design and execute. Because combination therapies involve multiple drugs, researchers must carefully evaluate the safety and efficacy of each individual drug, as well as the interactions between them. This can require a large number of participants and a long duration of follow-up, which can be expensive and time-consuming. 

Solutions for Combination Immunotherapy Clinical Trials  

The promising results of combination immunotherapies make it worth finding ways to overcome the challenges. 

Study Design and Protocol Development Support 

Because combination immunotherapy clinical trials are often complex, it is helpful to have support with study design and protocol development. Employing a team of medical, scientific, and statistical consultants, experienced in designing and conducting clinical trials, can help you design studies that are scientifically sound and feasible to implement. as well as provide guidance on how to integrate multiple therapies into a single protocol and ensure that the study is well-powered to detect a treatment effect. 

Enhance Patient Enrollment and Recruitment  

Another solution is to offer support with patient enrollment and recruitment. Clinical research organizations often have access to a large network of research sites which can help you find suitable sites to eventually identify and enroll eligible participants quickly and efficiently. They can also provide resources and expertise to support clients in overcoming common challenges such as slow enrollment and patient dropout. 

Data Management and Analysis Services 

A third solution is to provide support with data management and analysis. Specialized software and services from CROs  help clients manage, analyze, and interpret the large and complex datasets generated by combination immunotherapy trials. Many organizations also provide expertise in statistical methods and predictive modeling, which can help in identifying trends and patterns in the data that may be useful for understanding the mechanisms of action and safety of the therapies being studied. 

In conclusion, combination immunotherapies have the potential to offer significant benefits to cancer patients, but conducting clinical trials for these treatments can be challenging. Clinical research organizations, such as Allucent, can provide support with study design, site selection, patient enrollment, and data management, which can help researchers overcome these challenges and advance the field of cancer immunotherapy.  

By combining the expertise of clients and Allucent, we aim to accelerate the development of effective and safe combination therapies and improve the lives of cancer patients around the world.