Is NCT05155033 recruiting in Bethesda, MD?

Yes, NCT05155033 is currently recruiting participants at its Bethesda, MD location. This metastatic melanoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic melanoma clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Melanoma Clinical Trial in Bethesda, MD

About This Metastatic Melanoma Study in Bethesda

Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma. Researchers want to see if these drugs can be used together to produce better results in people with these types of cancer. Objective: To learn if the combination of pembrolizumab and aldesleukin can be used to treat metastatic or advanced melanoma and renal cell cancer. Eligibility: Adults aged 18 years or older who have metastatic or advanced melanoma or renal cell carcinoma. Design: Participants will be screened with: * Medical history * Physical exam * Electrocardiogram * Blood and urine tests * Ability to perform tasks of daily living * Imaging scans (CT, MRI, PET, and/or X-rays). They may get a contrast agent to enhance the images. * Photographs, if needed Some of these tests will be repeated during the study. Participants will receive the study drugs by IV (a plastic tube that is put into a vein) for 4 days. A second cycle of treatment will be given 21 days later. They will stay in the hospital for each of the cycles in the first course of treatment. After 2 months, their cancer will be evaluated. They may receive a second course of pembrolizumab alone on Days 1 and 21. They will not have to stay in the hospital for this course. About 30 days after treatment ends, participants will have a safety follow-up visit. Then they will have visits every 3 months for up to 1 year, and then every 6 months for up to 4 years. Follow-up can also be done by phone, email, and mail. If their cancer gets worse, they will stop having visits. Participation will last for 5 years....

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05155033) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Melanoma Treatment Options in Bethesda, MD

If you're searching for metastatic melanoma treatment options in Bethesda, MD, this clinical trial (NCT05155033) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic melanoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Melanoma Clinical Trial in Bethesda, MD

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