CompletedPhase 2

LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

United States27 participantsStarted 2020-11-17

Plain-language summary

A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in combination with a programmed death receptor-1 (anti-PD-1) inhibitor.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 18 years of age
✓. Prior CDC-recommended vaccination series against PV, and has received a boost immunization with trivalent IPOL® (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Day 1
✓. Has biopsy proven unresectable cutaneous melanoma and is willing to undergo tumor biopsy prior to the first dose of study drugs and at prespecified intervals during the study
✓. Patients with ocular, acral or mucosal melanoma are not eligible
✓. Patients with M1c or M1d disease are NOT eligble.
✓. Submission of an archival biopsy sample is allowed in lieu of the baseline tumor biopsy, provided the tissue is ≤4 months old and the participant received no intervening systemic/intratumoral anti-cancer therapy since the biopsy was acquired.
✓. Must have at least 1 lesion that is amenable to biopsy. The lesion must be safely accessible as determined by the investigator and should not be located at sites that require significant risk procedures to biopsy. Examples of sites considered to be of significant risk include but are not limited to the following: the brain, lung, mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel wall.
✓. Has ≥ 2 melanoma lesions that are accurately measurable by caliper or a radiological method according to RECIST 1.1 criteria

Exclusion criteria

✕. Has biopsy-proven ocular, acral or mucosal melanoma
✕. Has M1c or M1d disease
✕. No more than one prior systemic anti-cancer regimen (monotherapy or combination) for management of melanoma. Additional details noted below:
✕. Adjuvant anti-cancer therapy administered ≥ 6 months prior to the first injection of lerapolturev does NOT count as a line of treatment.
✕. Patients with BRAF mutant melanoma may enroll if they have received ≤ 2 prior lines of systemic anti-cancer therapy only if one of those lines of therapy was a BRAF-targeted regimen (alone or in combination with MEK inhibitor).
✕. A line of therapy is defined as a regimen in which at least 2 doses of systemic anti-cancer therapy (monotherapy or combination) was administered, and the regimen was discontinued because of progressive disease
✕. Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
✕. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period

What they're measuring

Overall Response

Timeframe: 24 months

Number of Participants Experiencing a Treatment-emergent Adverse Event

Timeframe: 24 months

Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs)

Timeframe: 24 months

Number of Participants Discontinuing Study Treatment Due to Adverse Event(s)

Timeframe: 24 months

Changes From Baseline in the Number of CD8+ Tumor Infiltrating Lymphocytes (TILs)

Timeframe: 24 months

Changes From Baseline in PD-L1 Expression

Timeframe: 24 months

Trial details

NCT IDNCT04577807

SponsorIstari Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

Results submitted2025-06-04

View on ClinicalTrials.gov More Melanoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 18 years of age
✓. Prior CDC-recommended vaccination series against PV, and has received a boost immunization with trivalent IPOL® (Sanofi-Pasteur SA) at least 1 week, but less than 6 weeks, prior to Day 1
✓. Has biopsy proven unresectable cutaneous melanoma and is willing to undergo tumor biopsy prior to the first dose of study drugs and at prespecified intervals during the study
✓. Patients with ocular, acral or mucosal melanoma are not eligible
✓. Patients with M1c or M1d disease are NOT eligble.
✓. Submission of an archival biopsy sample is allowed in lieu of the baseline tumor biopsy, provided the tissue is ≤4 months old and the participant received no intervening systemic/intratumoral anti-cancer therapy since the biopsy was acquired.
✓. Must have at least 1 lesion that is amenable to biopsy. The lesion must be safely accessible as determined by the investigator and should not be located at sites that require significant risk procedures to biopsy. Examples of sites considered to be of significant risk include but are not limited to the following: the brain, lung, mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel wall.
✓. Has ≥ 2 melanoma lesions that are accurately measurable by caliper or a radiological method according to RECIST 1.1 criteria

Exclusion criteria

✕. Has biopsy-proven ocular, acral or mucosal melanoma
✕. Has M1c or M1d disease
✕. No more than one prior systemic anti-cancer regimen (monotherapy or combination) for management of melanoma. Additional details noted below:
✕. Adjuvant anti-cancer therapy administered ≥ 6 months prior to the first injection of lerapolturev does NOT count as a line of treatment.
✕. Patients with BRAF mutant melanoma may enroll if they have received ≤ 2 prior lines of systemic anti-cancer therapy only if one of those lines of therapy was a BRAF-targeted regimen (alone or in combination with MEK inhibitor).
✕. A line of therapy is defined as a regimen in which at least 2 doses of systemic anti-cancer therapy (monotherapy or combination) was administered, and the regimen was discontinued because of progressive disease
✕. Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.
✕. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period

What they're measuring

Overall Response

Timeframe: 24 months

Number of Participants Experiencing a Treatment-emergent Adverse Event

Timeframe: 24 months

Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs)

Timeframe: 24 months

Number of Participants Discontinuing Study Treatment Due to Adverse Event(s)

Timeframe: 24 months

Changes From Baseline in the Number of CD8+ Tumor Infiltrating Lymphocytes (TILs)

Timeframe: 24 months

Changes From Baseline in PD-L1 Expression

Timeframe: 24 months