A Phase I/II Study of Rovalpituzumab Tesirine with Nivolumab or Nivolumab/Ipilimumab Immunotherapy to Treat Persistent Extensive-Stage Small Cell Lung Cancer

Full Title

M16-300: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer


Rovalpituzumab tesirine is an investigational drug called an “antibody-drug conjugate.” The antibody seeks a protein on cancer cells, and once bound to that site, it releases a drug that kills the cancer cell. Rovalpituzumab tesirine binds to a protein called DLL3, which is found in high amounts on small cell lung cancer (SCLC) cells in some patients.

In this study, researchers are assessing the safety and effectiveness of combining rovalpituzumab tesirine with immunotherapy drugs in patients with extensive-stage SCLC that has continued to grow despite prior treatment. The other drugs are nivolumab and ipilimumab. They work by taking the brakes off the immune response, enabling the immune system to identify and kill cancer cells. Combining rovalpituzumab tesirine with these immunotherapy drugs may be more effective against SCLC than using them individually.

Patients in this study will receive either rovalpituzumab tesirine plus nivolumab, or rovalpituzumab tesirine with both nivolumab and ipilimumab. All of these medications are given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have extensive-stage SCLC that has continued to grow despite previous treatment that included platinum-based chemotherapy.
  • At least 2 weeks must pass between the completion of previous treatments and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Charles Rudin at 646-888-4336.