Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease

NCT04685499 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-12021148
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effects, of the research study drug Telomelysin (OBP-301) in combination with pembrolizumab in subjects with inoperable, recurrent, or progressive squamous cell carcinoma of the head and neck. Telomelysin is an investigational treatment, while pembrolizumab and SBRT are approved standard treatments. The combination of these three treatments is also considered investigational.

Conditions

Head and Neck Squamous Cell Carcinoma With Inoperable Recurrent or Progressive Disease

Keywords

Head and Neck; Recurrent; Cure; Unresectable; Immunotherapy; Oncolytic Virus; SBRT; Intratumoral injection

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate, as Assessed by Radiographic Imaging

  Examination of patients with a partial response or complete response.

  30 months

• 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.

  We will measure the rate of grade 3 or 4 adverse events attributed to the combination of multiple intratumoral injections of OBP-301 with SBRT and pembrolizumab.

  30 months

Secondary Outcomes (6)

• Disease Control Rate, as Assessed by Radiographic Imaging

  6 months

• Overall Survival, as Measured by the Rate of Survival in Patients

  30 months

• Progression Free Survival, as Assessed by Radiographic Imaging and Survival.

  30 months

• Duration of Response (DoR), as Measured by Subjects Who Have Responded to Combination Therapy Remain Without Disease Progression

  30 months

• Immune Related Response Rate (irRR), as Assessed by Radiographic Imaging

  30 months

Study Arms (1)

Telomelysin (OBP-301)

EXPERIMENTAL

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.

Drug: OBP-301; Drug: Pembrolizumab

Interventions

OBP-301 DRUG

Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions.

Also known as: Telomelysin

Telomelysin (OBP-301)

Pembrolizumab DRUG

Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year

Telomelysin (OBP-301)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Be \>18 years of age on the day of signing the informed consent.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have histologically or cytologically confirmed advanced head and neck squamous cell cancer with cutaneous, subcutaneous or nodal tumors deemed as injectable lesions \[see definition below\] and have measurable disease for the primary study endpoint of overall response rate by RECIST 1.1 and iRECIST.In addition they must have (A) A single measurable tumor at least 1 cm in size and amenable to intratumoral injection or (B) Multiple measurable tumors that in aggregate have a longest diameter of ≥ 10 mm
• Note: Injectable lesion definitions: lesions amenable to percutaneous approach, if technically feasible
• Recurrent and inoperable tumor, progressing after prior radiation with curative-intent for advanced disease (adjuvant or definitive with or without chemotherapy or cetuximab). No prior treatment for local regional recurrence (LRR).
• Tumors may be either HPV+ or HPV-.
• Tumor must be PD-L1 positive, defined as CPS ≥ 1.
• Be willing to provide tissue; newly obtained biopsy specimens or formalin-fixed, paraffin-embedded (FFPE) block specimens.
• Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. It is allowed that the test at the same day at 7 days prior to enrollment. And male / female subjects of childbearing potential must agree to use an adequate method of contraception starting with signing the informed consent through 120 days after the last dose of study medication.
• Demonstrated adequate organ function as defined in following criteria. All screening labs should be performed within 14 days of enrollment. Note: Subject must not have taken transfusion, hematopoietic agent; granulocyte-colony stimulating factor (G-CSF) etc., and/or oxygen supplementation within 7 days before the screening labs.
• Absolute neutrophil count (ANC)\>=1,000 /mm3
• Platelets\>=100,000 /mm3
• Hemoglobin\>=9.0 g/dL
• Serum total bilirubin\<=2.0 mg/dL

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 2 weeks (chemotherapy, small molecule), or 3 weeks (antibody) of study Day 1.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than the equivalent of prednisone 20 mg/day) or any other form of immunosuppressive therapy within 7 days prior to study Day 1. Daily dose of maintenance prednisone 10mg or equivalent is allowable.
• Has known active central nervous system metastases and/or carcinomatous meningitis.
• Has a known additional malignancy that is progressing or requires active treatment, with the exception of stable/low grade tumors that are not expected to influence life-expectancy (e.g. skin SCC, basal cell, differentiated thyroid cancer, prostate cancer on hormonal therapy).
• Has received a live vaccine within 30 days of planned start of study therapy.
• Has a known history of Human Immunodeficiency Virus.
• Has known active Hepatitis B or Hepatitis C.
• Has known history of, or any evidence of active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
• Previous severe hypersensitivity to another monoclonal antibody.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Prior intolerance related to severe (\>=grade 3) irAE to a prior anti-immune checkpoint inhibitor agent leading to discontinuation of anti-immune checkpoint inhibitor therapy.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Oncolys BioPharma Inc: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Disease Progression; Recurrence

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Meyer Cancer Center GI Program Manager
• Organization: Weill Cornell Medicine

cdo4001@med.cornell.edu

646-962-8189

Study Officials

• Doru Paul, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: May 3, 2021
• Primary Completion: March 8, 2022
• Study Completion: June 3, 2022
• Last Updated: January 11, 2023
• Results First Posted: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)