Is NCT05077137 recruiting in Durham, NC?

Yes, NCT05077137 is currently recruiting participants at its Durham, NC location. This melanoma clinical trial is actively enrolling qualified participants.

How do I join the melanoma clinical trial in Durham?

To join this clinical trial in Durham, 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 Durham 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.

Melanoma Clinical Trial in Durham, NC

About This Melanoma Study in Durham

The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

Histologically confirmed advanced metastatic melanoma

Male or female participants who are at least 18 years of age on the day of signing informed consent

Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care

Participant (or legally acceptable representative if applicable) provides written informed consent for the trial

Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion

Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility

ANC \>/= 1500/uL

platelets \>/=100,000/uL

Hemoglobin \>/= 9.0 g/dL

Exclusion Criteria

Uveal or mucosal melanoma

Any women known to be pregnant or breastfeeding

Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)

Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy

Patients with symptomatic CNS metastases and/or carcinomatous meningitis a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on \>10mg prednisone daily

History of or active (non-infectious) pneumonitis that required steroids

Active infection requiring systemic therapy

Known history of Human Immunodeficiency Virus (HIV) infection

Known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required

Known history of active TB (Bacillus Tuberculosis)

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

History of allogenic tissue or solid organ transplant

History of allergic reaction to IPOL or Td vaccine

Receipt of Td vaccine within 30 days prior to starting IO therapy

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 Durham?

Yes, this clinical trial (NCT05077137) has an active research site in Durham, NC 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.

Melanoma Treatment Options in Durham, NC

If you're searching for melanoma treatment options in Durham, NC, this clinical trial (NCT05077137) 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 Durham research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced 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 melanoma clinical trials near you to find additional studies recruiting in your area.

Melanoma Clinical Trial in Durham, NC

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IRB Approved

No-Cost Care

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