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New treatment option for Metastatic Melanoma
Official title Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT05155033
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have histologically or cytologically confirmed cancer that falls into one of three cohorts: (1) metastatic melanoma or advanced...
- 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.
You likely can't 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...
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.