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Virus Therapy

OBP-301 for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Led By Doru Paul, MD
Research Sponsored by Weill Medical College of Cornell University
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 30 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of treatments may be more effective than each treatment alone.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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
Occurrence of Significant Toxicity, as Measured by Number of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to the Combination of Multiple Intratumoral Injections of OBP-301 With SBRT and Pembrolizumab.
Overall Response Rate, as Assessed by Radiographic Imaging
Secondary outcome measures
Disease Control Rate, as Assessed by Radiographic Imaging
Duration of Response (DoR), as Measured by Subjects Who Have Responded to Combination Therapy Remain Without Disease Progression
Immune Related Response Rate (irRR), as Assessed by Radiographic Imaging
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Telomelysin (OBP-301)Experimental Treatment2 Interventions
All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OBP-301
2017
Completed Phase 1
~30
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,294 Total Patients Enrolled
Oncolys BioPharma IncIndustry Sponsor
7 Previous Clinical Trials
117 Total Patients Enrolled
Doru Paul, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
4 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
Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease
2021. "Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04685499.
~0 spots leftby Apr 2025
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