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PD-L1 Inhibitor

ONCOS-102 for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Ludwig Institute for Cancer Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months
Awards & highlights

Study Summary

This study is evaluating whether a virus which infects white blood cells and a drug which targets a protein on the surface of cancer cells may help treat ovarian and colorectal cancer.

Eligible Conditions
  • Colorectal Cancer
  • Ovarian Cancer
  • Appendiceal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs)
Progression-free Survival (PFS) at Week 24 as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method
Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 67 Patients • NCT02963831
100%
Chills
75%
Pyrexia
75%
Fatigue
75%
Anaemia
50%
Weight decreased
50%
Headache
50%
Dyspnoea
50%
Abdominal pain
50%
Nausea
50%
Vomiting
50%
Malaise
50%
Small intestinal obstruction
50%
Diarrhoea
50%
Abdominal distention
50%
Hypokalaemia
25%
Pain
25%
Pleural effusion
25%
Electrocardiogram QT prolonged
25%
Large intestinal obstruction
25%
Gastrooesophageal reflux disease
25%
Early satiety
25%
Rib fracture
25%
Disturbance in attention
25%
Urinary retention
25%
Malignant neoplasm progression
25%
Insomnia
25%
Hyponatraemia
25%
Anxiety
25%
Oedema peripheral
25%
Constipation
25%
Ascites
25%
Retching
25%
Carbohydrate antigen 125 increased
25%
Decreased appetite
25%
Hypomagnesaemia
25%
Myalgia
25%
Cough
25%
Night sweats
25%
Back pain
25%
Abdominal pain upper
25%
Pruritus
25%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: ONCOS-102 Dose Escalation
Cohort 2: Metastatic Colorectal Cancer
Cohort 1: Epithelial Ovarian Cancer
Cohort B ONCOS-102 Dose Escalation

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort B: ONCOS-102 Dose EscalationExperimental Treatment3 Interventions
ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better.
Group II: Cohort A: ONCOS-102 Dose EscalationExperimental Treatment3 Interventions
ONCOS-102, 1 x 10^11 viral particles (VPs) monotherapy for 6 weeks, followed by durvalumab 1500 mg starting on Day 71. A bolus dose of 300 mg cyclophosphamide (CPO) was administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused intraperitoneally (IP) in a total volume of 500 mL saline (0.9 mg/mL sodium chloride [NaCl] in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose every 4 weeks (Q4W) for 10 cycles, starting on Day 71. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better.
Group III: Cohort 2: Metastatic Colorectal CancerExperimental Treatment3 Interventions
ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better.
Group IV: Cohort 1: Epithelial Ovarian CancerExperimental Treatment3 Interventions
ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONCOS-102
2012
Completed Phase 2
~100
Durvalumab
2017
Completed Phase 2
~3870
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Ludwig Institute for Cancer ResearchLead Sponsor
60 Previous Clinical Trials
1,553 Total Patients Enrolled
Cancer Research Institute, New York CityOTHER
20 Previous Clinical Trials
1,232 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,842 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
2017. "A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02963831.
~9 spots leftby Apr 2025
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