So I am pretty sure that I am going to be starting Yervoy at UVA next week. Before that, I wanted to make sure that I researched all the PD-1 trails I could find. It doesn't look like there are many out there. I'm not eligible for the Moffitt study (have to fail ipi first). The others are not recruiting. Study #1, #5, and #6 are possibilities, but they are Phase 1, and that is concerning to me.
Right now my doc wants to do Yervoy. If I don't respond, then we can try for the Moffitt study. I'd love some feedback if you have any.
Question: Is Yervoy considered to be an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PDL-2, or anti-Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody type therapy? Will taking ipi cause me to become ineligible for studies 3 & 4?
Here is what I found:
- Memorial Sloan Kettering & Yale School of Medicine
- Requires a tissue sample (UVA banked my ovary)
- Moffitt study... have to fail ipi first
- Exclusion Note: Prior therapy with an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PDL-2, or anti- Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody (or any other antibody targeting T cell co- stimulation pathways)
- Johns Hopkins would be closest location
- UVA will be participating
- Must have a lesion that can be biopsied
- Exclusion Note: Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX- 40,and anti-CD40 antibodies. However, half the patients must have progressed on anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) monoclonal antibody therapy
5. J08113: Phase Ib Multicenter Multidose Study of an Anti-PD-1 Monoclonal Antibody (MDX-1106) in Patients with Selected Refractory or Relapsed Malignancies. This clinical trial is designed to evaluate the safety and tolerability of the human monoclonal antibody MDX-1106 in treating patients with advanced cancers. MDX-1106 blocks PD-1, a molecule found on the surface of activated T lymphocytes (immune cells). Normally, PD-1 dampens immune responses at the appropriate time, turning off immune activation. However, laboratory evidence suggests that PD-1 may also suppress immune responses against cancer, and that blocking PD-1 may enhance anti-tumor immunity thereby controlling tumor growth. This is the second trial to evaluate MDX-1106 in cancer patients. In the first-in-human clinical trial recently conducted at Johns Hopkins and 3 other centers, patients received progressively higher doses of MDX-1106 as a single intravenous infusion every 1-3 months. Tumor regressions were observed in some patients with melanoma, kidney, colon and lung cancer, and there were minimal side effects. This new trial will use more frequent dosing of MDX-1106, every 2 weeks in 2-month cycles. Patients with advanced metastatic melanoma (stage III or IV) whose disease has recurred after standard treatment may be eligible for enrollment, regardless of the site of their original melanoma (skin, eye, mucosal, unknown). In addition to melanoma, patients with advanced cancers of the kidney, lung and prostate will be included. Because MDX-1106 has immune stimulatory properties, patients with autoimmune diseases are not eligible. http://www.hopkinsmedicine.org/kimmel_cancer_center/centers/melanoma/clinical_trials/
6. J0918: A Phase 1, Open-label, Multicenter, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects with Selected Advanced or Recurrent Solid Tumors. This is a first-in-human phase I trial of a monoclonal antibody targeting Programmed Death Ligand 1 (PD-L1). PD-L1 is a molecule involved in inhibiting the immune system, such that in healthy patients it protects against certain autoimmune diseases. In patients with cancer, however, PD-L1 is often expressed on the tumor cell surface and may diminish the efficacy of an immunologic anti-tumor attack. MDX-1105 blocks PD-L1, thereby allowing the patient’s immune system to more readily recognize and destroy cancer cells. The primary objective of this study is to assess the safety and tolerability of MDX-1105 when administered intravenously every 14 days, and to determine the maximum tolerated dose of this drug. The trial is also designed to evaluate the anti-tumor effects and pharmacologic properties of MDX-1105. Nearly 300 subjects with measurable, advanced, recurrent melanoma or other tumors, including cancers of the lung, ovary, kidney, colon, stomach, pancreas, and breast will be enrolled. Participants with melanoma must have unresectable treatment-refractory Stage III or IV disease. All melanomas regardless of primary site of disease will be allowed. Patients must have a good performance status and adequate hematologic, renal and hepatic function. Prior chemotherapy or IL-2 is allowed, but patients who have undergone therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other agents that target T cell co-stimulation, will not be eligible. http://www.hopkinsmedicine.org/kimmel_cancer_center/centers/melanoma/clinical_trials/