A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade
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ClinicalTrials.gov Identifier: NCT03003676 |
Recruitment Status :
Completed
First Posted : December 28, 2016
Results First Posted : August 9, 2021
Last Update Posted : November 8, 2021
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Advanced or Unresectable Melanoma Progressing After PD1 Blockade |
Interventions |
Biological: ONCOS-102 Drug: Cyclophosphamide Drug: Pembrolizumab |
Enrollment | 21 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 1 | Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab - Part 2 |
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Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will receive pembrolizumab i.v., 2mg/kg or 200 mg flat dose on day 22 (Week 3) and every three weeks thereafter until Day 169/Week 24. ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade |
Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose). ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade |
Period Title: Overall Study | ||
Started | 9 | 12 |
Completed | 3 | 4 |
Not Completed | 6 | 8 |
Reason Not Completed | ||
Lack of Efficacy | 5 | 7 |
Withdrawal by Subject | 0 | 1 |
Hepatitis B infection | 1 | 0 |
Arm/Group Title | Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 1 | Experimental: ONCOS-102+Cyclophosphamide+Pembrolizumab Part 2 | Total | |
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Part I: Patients will receive 3 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, and 8) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. They will then receive pembrolizumab i.v., 2mg/kg or 200mg flat dose, on day 22 (Week 3) and every 3 weeks thereafter until the end of treatment visit on day 169 (Week 24). ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade |
Part II: Patients will receive 4 doses of intratumoral (i.t.) injection of ONCOS-102 (days 1, 4, 8 and 15) at 3x10^11 viral particles (VP), preceded by intravenous (i.v.) cyclophosphamide priming 1-3 days prior to day 1. ONCOS-102 will be given in combination with Pembrolizumab starting on Day 22/Week 3 and every three weeks thereafter until Day 169/Week 24 or until unacceptable toxicity or clinically relevant disease progression, whichever occurs first. Pembrolizumab will be given according to institutional practice (2mg/kg or 200mg flat dose). ONCOS-102: Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF) Cyclophosphamide: Pre-treatment Pembrolizumab: PD1 blockade |
Total of all reporting groups | |
Overall Number of Baseline Participants | 9 | 12 | 21 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 12 participants | 21 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
2 22.2%
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6 50.0%
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8 38.1%
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>=65 years |
7 77.8%
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6 50.0%
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13 61.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 9 participants | 12 participants | 21 participants | |
69.1 (13.68) | 67.3 (13.50) | 68.1 (13.26) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 12 participants | 21 participants | |
Female |
4 44.4%
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6 50.0%
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10 47.6%
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Male |
5 55.6%
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6 50.0%
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11 52.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 12 participants | 21 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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1 8.3%
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1 4.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 11.1%
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0 0.0%
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1 4.8%
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White |
8 88.9%
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11 91.7%
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19 90.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 9 participants | 12 participants | 21 participants |
United States | 8 | 10 | 18 | |
Norway | 1 | 2 | 3 |
Name/Title: | Dr. Lone H. Ottesen, Chief Development Officer |
Organization: | Targovax |
Phone: | +44 7920567911 |
EMail: | lone.ottesen@targovax.com |
Responsible Party: | Targovax ASA ( Targovax Oy ) |
ClinicalTrials.gov Identifier: | NCT03003676 |
Other Study ID Numbers: |
ONCOS C824 |
First Submitted: | December 19, 2016 |
First Posted: | December 28, 2016 |
Results First Submitted: | July 16, 2021 |
Results First Posted: | August 9, 2021 |
Last Update Posted: | November 8, 2021 |