10057 Phase II Study of Talimogene laherparepvec Followed by Talimogene laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the effectiveness of the study drug T-VEC in non-melanoma skin cancers and rare lymphomas, and if T-VEC is not effective, to test the effectiveness of T-VEC + nivolumab in combination.
Patients with lymphoma that is unable to be removed with surgery, has spread from where it started to another part of your body, or recurrent despite standard treatments.
Study participants will have certain types of skin cancers or certain types of lymphomas that involve the skin and/or lymph nodes. T-VEC is administered by injecting it directly into your tumor in the clinic or treatment center. Therefore, all study participants must have at least one tumor that can be seen or felt on physical examination. All study participants will receive the same study drug, T-VEC, which is administered by injection directly into a tumor. The first cycle is 21 days long, and all remaining cycles are 14 days long, so starting with Week 4, you will get the T-VEC injection every two weeks. Nivolumab may not be added until Week 12. If your cancer has not shrunk by Week 12, your doctor will add nivolumab to your treatment program. If your doctor decides to keep treating you with T-VEC alone and your tumor(s) start to grow, your doctor will have the option to add nivolumab to your treatment program.If the study doctor decides to add nivolumab after Week 12, it will be given every two weeks on the same day as T-VEC. Nivolumab is given into the vein and the infusion takes approximately 60 minutes.In the event that your injected tumor(s) completely disappears (no tumors left to inject), you will be allowed to continue to receive nivolumab alone until the end of the treatment period (Week 52). You will be asked to have tumor assessments (examinations and/or scans) at Baseline, Week 6, Week 12 and every 12 weeks thereafter. You will receive the study drugs for up to 1 year. During this time, you will receive the study drugs until your cancer becomes worse or your study doctor believes it is no longer working for you. After you finish taking the study drugs, your doctor will continue to watch you for side effects and follow your condition for up to 1 year or until symptoms resolve or stabilize with office visits and tests every 3 months. You may be contacted by phone or electronic means every 3 months for up to 3 years for updates on your status.
03/05/2019 05:03 AM