No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for adults with advanced melanoma who are receiving specific cancer treatments. Participants will receive a vaccine during their treatment and will provide blood and tissue samples for research.
Are You a Good Fit for This Trial?
Must be takingPD-1 therapyPD-1 plus anti CTLA-4 therapy
Rules you outHistory of solid organ transplantAllergic reaction to Td or IPOL vaccineReceived Td vaccine within 30 days prior to starting therapy
You may be able to join if
I have advanced metastatic melanoma
I am at least 18 years old
I am scheduled to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy
I can provide written consent for the trial
I have at least one lesion that is at least 8 mm in size
I have adequate organ function as confirmed by lab tests
You may not be able to join if
I have uveal or mucosal melanoma
I am pregnant or breastfeeding
I have received prior systemic therapy for metastatic melanoma
I have an immunodeficiency or take chronic steroids over 10 mg daily
I have symptomatic CNS metastases or carcinomatous meningitis
I have a history of non-infectious pneumonitis requiring steroids
I have an active infection that requires systemic therapy
I have a known history of HIV, active hepatitis B, hepatitis C, or active TB
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 sta…
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed advanced metastatic melanoma
2. Male or female participants who are at least 18 years of age on the day of signing informed consent
3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA…
Inclusion Criteria:
1. Histologically confirmed advanced metastatic melanoma
2. Male or female participants who are at least 18 years of age on the day of signing informed consent
3. 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
4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
5. 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
6. 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
1. ANC \>/= 1500/uL
2. platelets \>/=100,000/uL
3. Hemoglobin \>/= 9.0 g/dL
Exclusion Criteria:
1. Uveal or mucosal melanoma
2. Any women known to be pregnant or breastfeeding
3. Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)
4. 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
5. 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
6. History of or active (non-infectious) pneumonitis that required steroids
7. Active infection requiring systemic therapy
8. Known history of Human Immunodeficiency Virus (HIV) infection
9. 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
10. Known history of active TB (Bacillus Tuberculosis)
11. 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
12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
13. History of allogenic tissue or solid organ transplant
14. History of allergic reaction to IPOL or Td vaccine
15. Receipt of Td vaccine within 30 days prior to starting IO therapy
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