Authorised Therapeutic confirmatory (Phase III) High risk resected melanoma.

S1404: A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma.

EU CTIS ID: 2024-516881-12-00

What this study is testing

a. To compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab versus MK-3475 (pembrolizumab). b. Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab versus MK-3475 (pembrolizumab). c. To compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with physician/patient choice.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Step 1 Registration: Disease Related Criteria: Patients must have completely resected melanoma of cutaneous origin or of unknown primary. Patients must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma. Patients with non-ulcerated T1b N1a disease are not eligible. Patients with melanoma of mucosal or other non-cutaneous origin are eligible. Patients with melanoma of ocular origin are not eligible. Patients with a history of brain metastases are ineligible.
  • Step 1 Registration: Clinical/Laboratory Criteria: All patients must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to registration. Refer to protocol for imaging requirements.
  • Step 1 Registration: Clinical/Laboratory Criteria: All patients must have a CT or MRI of the brain within 90 days prior to registration (with intravenous contrast (unless contraindicated)).
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500 mcL; platelets ≥ 100,000/mcL; Hemoglobin ≥ 10 g/dL.
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate hepatic function as evidenced by the following: total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dL), and SGOT (AST) and SGPT (ALT) and alkaline phosphatase ≤ 2 x IULN.
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate renal function as evidenced by ONE of the following: serum creatinine ≤ IULN OR measured or calculated creatinine clearance ≥ 60 mL/min.

You likely can't join if

  • Step 1 Registration: Prior/Concurrent Therapy Criteria: Patients must not have received neoadjuvant treatment for their melanoma. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti-PD-L1 intra-tumoral or vaccine therapies. Patients must not be planning to receive any of the prohibited therapies listed in protocol Section 7.2 during the screening or treatment phases of the study.
  • Step 1 Registration: Clinical/Laboratory Criteria: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated Stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • Step 1 Registration: Prior/Concurrent Therapy Criteria: Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery or other therapy after Step 2 registration.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have an active infection requiring systemic therapy.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
See the full eligibility criteria
Who can join
  • Step 1 Registration: Disease Related Criteria: Patients must have completely resected melanoma of cutaneous origin or of unknown primary. Patients must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma. Patients with non-ulcerated T1b N1a disease are not eligible. Patients with melanoma of mucosal or other non-cutaneous origin are eligible. Patients with melanoma of ocular origin are not eligible. Patients with a history of brain metastases are ineligible.
  • Step 1 Registration: Clinical/Laboratory Criteria: All patients must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to registration. Refer to protocol for imaging requirements.
  • Step 1 Registration: Clinical/Laboratory Criteria: All patients must have a CT or MRI of the brain within 90 days prior to registration (with intravenous contrast (unless contraindicated)).
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500 mcL; platelets ≥ 100,000/mcL; Hemoglobin ≥ 10 g/dL.
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate hepatic function as evidenced by the following: total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s Syndrome, who must have a total bilirubin < 3.0 mg/dL), and SGOT (AST) and SGPT (ALT) and alkaline phosphatase ≤ 2 x IULN.
  • Step 1 Registration: Clinical/Laboratory Criteria: Adequate renal function as evidenced by ONE of the following: serum creatinine ≤ IULN OR measured or calculated creatinine clearance ≥ 60 mL/min.
  • Step 1 Registration: Clinical/Laboratory Criteria: LDH performed within 42 days prior to registration.
  • Step 1 Registration: Clinical/Laboratory Criteria: Zubrod Performance Status ≤ 1.
  • Step 1 Registration: Clinical/Laboratory Criteria: A baseline ECG performed within 42 days of registration that is normal or considered not clinically significant.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate CD4 counts (≥ 350 mm3), and serum HIV viral load of < 25,000 IU/ml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria.
  • Step 1 Registration: Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication.
  • Step 1 Registration: Disease Related Criteria: Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by H & E stained slides.
  • Step 1 Registration: Patients who are able to complete questionnaires in English, Spanish or French must participate in the quality of life assessments. (Those patients who cannot complete the quality of life questionnaires can be registered to S1404.
  • Step 2 Registration (Randomization): Women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
  • Step 2 Registration (Randomization): Patients who are known to have a change in eligibility status after Step 1 registration are not eligible for Step 2 registration.
  • Step 1 Registration: Disease Related Criteria: Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
  • Step 1 Registration: Disease Related Criteria: Patients at initial presentation of melanoma must undergo an adequate wide excision of the primary lesion, if present. Patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site. A full lymphadenectomy is required for all node-positive patients including those with positive sentinel nodes. Patients with recurrent disease who have had a prior complete lymphadenectomy fulfill this requirement as long as all recurrent disease has been resected. For all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma. Patients must be registered within 98 days of the last surgery performed to render the patient free of disease.
  • Step 1 Registration: Specimen Submission Criteria: Patients must have available and be willing to submit a minimum of 5 unstained slides from primary, lymph node, or metastatic site to determine PD-L1 expression.
  • Step 1 Registration: Specimen Submission Criteria: Patients must be offered the opportunity to participate in specimen banking.
  • Step 1 Registration: Specimen Submission Criteria: Patients must be willing to have blood draws for PK/ADA ( MK-3475 arm).
  • Step 1 Registration: Prior/Concurrent Therapy Criteria: Patients may have received prior radiation therapy, including after the surgical resection. All AEs associated with prior surgery and radiation therapy must have resolved to ≤ Grade 1 prior to registration.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must be ≥ 18 years of age.
What rules you out
  • Step 1 Registration: Prior/Concurrent Therapy Criteria: Patients must not have received neoadjuvant treatment for their melanoma. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti-PD-L1 intra-tumoral or vaccine therapies. Patients must not be planning to receive any of the prohibited therapies listed in protocol Section 7.2 during the screening or treatment phases of the study.
  • Step 1 Registration: Clinical/Laboratory Criteria: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated Stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • Step 1 Registration: Prior/Concurrent Therapy Criteria: Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery or other therapy after Step 2 registration.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have an active infection requiring systemic therapy.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have received live vaccines within 42 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection prior to registration.
  • Step 1 Registration: Clinical/Laboratory Criteria: Patients must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the trial results, interfere with the patient's participation for the full duration of the trial, or indicate that participation in the trial is not in the patient's best interests, in the opinion of the treating investigator.

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.