TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age18 Years to 120 Years
- SexAll
- Healthy volunteersNo
You may be able to join if
- INCLUSION CRITERIA:
- Participants must have histologically or cytologically confirmed cancer that falls into one of three cohorts: (1) metastatic melanoma or advanced locoregional melanoma not amenable to curative surgical resection and refractory to anti-PD-1 therapy; (2) metastatic renal cell carcinoma (clear cell histology) refractory to at least one line of PD1/PDL1 based therapy; (3) metastatic or advanced locoregional melanoma not amenable to curative surgical resection and naive to anti-PD-1 therapy.
- Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer.
- Age >=18 years of age.
- Clinical performance status of ECOG 0 or 1.
- Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
- Must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
- Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
- Participants must have adequate organ and marrow function as defined below:
- ANC > 1000/mm^3 without the support of filgrastim
- WBC >= 3000/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin > 8.0 g/d (Subject may be transfused to reach this cut-off)
- Serum ALT/AST <= 5.0 x ULN
- Serum creatinine <= 1.6 mg/dL
- Total bilirubin <= 2.0 mg/dL, except in participants with Gilbert s Syndrome, who must have a total bilirubin < 3.0 mg/dL.
- More than four weeks must have elapsed since completion of any prior systemic therapy at the time of enrollment.
- Note: Participant may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to <= grade 1.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willing to sign a Durable Power of Attorney Form.
- Subject must be co-enrolled on protocol 03-C-0277
You cannot join if
- Participant is nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Concurrent systemic steroid therapy.
- Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- History of major organ autoimmune disease.
- Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1 monotherapy, including but not limited to myocarditis, pneumonitis, colitis, and hepatotoxicity.
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- History of severe immediate hypersensitivity reaction to pembrolizumab or aldesleukin.
- History of coronary revascularization or ischemic symptoms.
- For select participants with a clinical history prompting cardiac evaluation: last known LVEF <= 45%.
- For select participants with a clinical history prompting pulmonary evaluation: known FEV1 <= 50%.
- Participant is receiving any other investigational agents.