Recruiting PHASE3 Advanced Melanoma

Compares treatment options for Advanced Melanoma

Official title VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

ClinicalTrials.gov ID: NCT06264180

What this study is testing

What is Vusolimogene Oderparepvec?

Vusolimogene Oderparepvec is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced melanoma.

Also referred to as VO, RP1.

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: This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

Phase 3: a large, late-stage study
Which group you join is decided by chance.

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

Who can take part

Ages 12 and older

You may be able to join if

Key I 1. Male or female who is 12 years of age or older at the time of signed informed consent. I 2. Patients with histologically or cytologically...
Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (note: treatment with prior pembrolizumab therapy when...
Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody (eg, due to documented clinically significant...
Disease progression must have been confirmed and documented using clinical or radiological assessment by 2 assessments at least 4 weeks apart while...
White blood cell (WBC) count ≥ 2.0 × 109/L

You likely can't join if

E 1. Primary mucosal or uveal melanoma. E 2. More than 2 lines of systemic therapy for advanced melanoma. Note: One additional line of anti-PD-1...
E 3. Known acute or chronic hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known acute or chronic hepatitis C virus...
Note: Patients who have been effectively treated are eligible for randomization. Patients must be negative for HBsAg and HCV RNA.
E 4. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or...
E 5. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires...
Note: Patients with sporadic cold sores may be assigned by chance if no active cold sores are present at the time of first dose of study treatment.

See the full eligibility criteria

Who can join

Key I 1. Male or female who is 12 years of age or older at the time of signed informed consent. I 2. Patients with histologically or cytologically confirmed unresectable or metastatic Stage IIIb through IV/M1a through...
Treatment with prior anti-PD-1 therapy must have continued for a minimum of 8 weeks (note: treatment with prior pembrolizumab therapy when administered every 6 weeks must have continued for a minimum of 12 weeks [ie, 2...
Patients who in the physician's judgement are not candidates for treatment with an anti-CTLA-4 antibody (eg, due to documented clinically significant comorbidities or history of immune-related adverse events) are...
Disease progression must have been confirmed and documented using clinical or radiological assessment by 2 assessments at least 4 weeks apart while being treated with an anti-PD-1 antibody and an anti-CTLA-4 antibody...
White blood cell (WBC) count ≥ 2.0 × 109/L
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
Platelet count ≥ 75 × 109/L
Hemoglobin ≥ 8 g/dL (without packed red blood cell [RBC] transfusion within 2 weeks of dosing) I 7. Has adequate hepatic function, including:
Total bilirubin ≤ 1.5 × upper limit of normal (ULN; \< 2.0 × ULN for patients with known Gilbert syndrome or liver metastases)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × ULN (or ≤ 5.0 × ULN, if liver metastases are present)
Alkaline phosphatase (ALP) ≤ 2.5 × ULN (or ≤ 5.0 × ULN, if liver or bone metastases are present) I 8. Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 3 0 mL/minute/1.73 m2...

What rules you out

E 1. Primary mucosal or uveal melanoma. E 2. More than 2 lines of systemic therapy for advanced melanoma. Note: One additional line of anti-PD-1 therapy in the adjuvant or neoadjuvant setting is allowed if the patient...
E 3. Known acute or chronic hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known acute or chronic hepatitis C virus (defined as HCV RNA [qualitative] is detected).
Note: Patients who have been effectively treated are eligible for randomization. Patients must be negative for HBsAg and HCV RNA.
E 4. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.
E 5. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known...
Note: Patients with sporadic cold sores may be assigned by chance if no active cold sores are present at the time of first dose of study treatment.
E 6. Had systemic infection requiring IV antibiotics or other serious active infection requiring antimicrobial, antiviral, or antifungal treatment within 14 days prior to the first dose.
E 7. Evidence of spinal cord compression or at high risk of spinal cord compression.
E 8. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis at time of screening. Patients with known central nervous system metastases are eligible if they have received standard-of-care...
E 9. Serum lactate dehydrogenase (LDH) \> 2 × ULN. E 10. Major surgery ≤ 2 weeks prior to starting study treatment. Note: Patients must have recovered adequately from all acute complications of all previous procedures...
E 11. Prior malignancy active within the previous 3 years, except for locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ...
E 12. History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled...
E 13. History of life-threatening toxicity related to prior immune therapy except those that are unlikely to recur with standard countermeasures (eg, hormone replacement after adrenal crisis).
E 14. History or evidence of psychiatric, substance abuse (including IV substance abuse), or any other clinically significant disorder, condition, or disease (with the exception of those described above) that, in the...
E 15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is...
E 16. Active, known, or suspected autoimmune disease requiring systemic treatment.
E 17. History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
E 18. Prior oncolytic virus therapy or other therapy given by intratumoral administration.
E 19. Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
E 20. Has received a live vaccine within 28 days prior to the first dose of study treatment.
E 21. Systemic anticancer therapies within 5 half-lives or 4 weeks of the first dose, whichever is shorter.
E 22. Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment.
E 23. Has received prior radiotherapy within 2 weeks of start of study treatment or has not recovered from radiotherapy.
E 24. Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy 14 days before randomization.
Note: Patients who require a brief course (≤ 7 days) or corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic...
E 25. History of allergy or sensitivity to study drug components (VO, nivolumab, pembrolizumab, or relatlimab) or to cisplatin or carboplatin or paclitaxel (dependent on cohort) or prior monoclonal antibody treatment.
E 26. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.
E 27. Is a person who is deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

The study team makes the final eligibility decision.

Where it's taking place

Gilbert, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Washington D.C., District of Columbia, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Iowa City, Iowa, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
Detroit, Michigan, United States

+ 52 more site(s).

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, 12 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Gilbert, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Sacramento, California, United States and 66 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.