Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer

• Status: Withdrawn
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and disease control rate of the combination of pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or renal cell cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Grosh, MD
• Treatments: Interleukin-2; Pembrolizumab

Criteria

Main Inclusion Criteria

• Stage IV or unresectable stage III malignant melanoma or renal cell carcinoma.

• Melanoma

• Patients must have failed anti-PD-1/PD-L1 antibody therapy.

• Patients must have failed ipilimumab or be intolerant of ipilimumab and therefore unable to receive ipilimumab.

• Patients may, but are not obligated, to have failed high- dose IL2.

• BRAF status must be known or unable to be performed. If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity.

• Renal Cell Carcinoma

• Patients must have failed anti-PD-1/PD-L1 antibody therapy.

• Patients must have failed a VEGF pathway inhibitor and a second tyrosine kinase inhibitor.

• Patients may, but are not obligated, to have failed high- dose IL2.

• Measurable disease based upon RECIST 1.1.

• Subjects with brain metastases will be eligible if the following are true:

• Subjects with ≤ 3 brain metastases

• All metastases are ≤ 3 cm

• All metastases have been treated and are asymptomatic

• Steroids are not required for management of the brain metastases

• All metastases have been stable for 1 month following treatment

• Subjects with > 3 brain metastases

• All metastases are ≤ 3 cm

• All metastases have been treated and are asymptomatic

• Steroids are not required for management of the brain metastases

• All metastases have been stable for 6 months following treatment

• Performance status: ECOG 0-1.

• Adequate organ function.

• Ability to provide informed consent.

Main Exclusion Criteria:

• Pregnancy

• Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.

• Has a diagnosis of primary or secondary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 3 weeks prior to the first dose of trial treatment. Replacement doses of steroids are permitted.

• Known history of active TB (Bacillus Tuberculosis)

• Hypersensitivity to pembrolizumab or any of its excipients.

• Known additional malignancies (exceptions DCIS or LCIS, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).

• Prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier.

• Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

• Known carcinomatous meningitis.

• Active autoimmune disease that has required systemic treatment in the past 2 years. Patients may be eligible if they have the following autoimmune diseases: thyroiditis or hypothyroidism, mild arthritis, diabetes, resolved hypophysitis, ulcerative colitis after total abdominal colectomy.

• Active infection requiring systemic therapy.

• Known psychiatric or substance abuse disorders.

• Known history of Human Immunodeficiency Virus (HIV).

• Known active Hepatitis B virus (HBV) or Hepatitis C virus (HCV).

• Has received a live vaccine within 30 days of planned start of study therapy.

• Severe chronic pulmonary disease.

• Congestive heart failure, angina, or symptomatic cardiac arrhythmia or is classified according to the New York Heart Association classification as having Class III or IV heart disease.

• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.