A Clinical Trial to compare the effectiveness of the study drug Tilsotomod (IMO-2125) given in combination with Ipilimumab and Nivolumab in subjects with solid tumors

Phase 1

• Conditions: Cohort 1: IO Naive Relapsed/Metastatic Squamous Cell Carcinoma of the Head and Neck; MedDRA version: 20.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003690-10-ES
• Lead Sponsor: Idera Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-08
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 41

Inclusion Criteria

1. Subject must be willing and able to sign the informed consent and comply with study protocol.
2. Must be = 18 years of age (males and females).
3. =1 lesion accessible for intratumoral injection and biopsy(ies).
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, minimum life expectancy = 4 months.
5. Adequate baseline organ function as defined by:
a) Absolute neutrophil count (ANC) = 1.5 x 109/L (1500/mm3)
b) Platelet count = 100 x 109/L (100,000/mm3)
c) Hemoglobin = 9.0 g/dL (5.59 mmol/L)
d) Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine clearance of = 40 mL/minute [= Grade 1] (measured or calculated using the Cockroft-Gault formula).
e) Aspartate aminotransferase (AST) = 3 x ULN, alanine aminotransferase (ALT) = 3 x ULN; AST/ALT <5 ULN if liver involvement
f) Serum bilirubin = 1.5 x ULN, except in subjects with Gilbert’s syndrome who must have a total bilirubin < 3mg/dL
6. Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to use effective contraception methods from screening for up to 5 months after last dose for women and update to 7 months after last dose for men (unless specified differently under eligibility criteria of a cohort) after the last dose of either tilsotolimod, nivolumab, or ipilimumab, whichever is later.
7. For any subject who received prior approved/investigational intratumoral anti-cancer treatments, the study's Medical Monitor must be consulted before enrollment.
8. Histologically and/or cytologically confirmed recurrent or metastatic, PD(L)1 negative or
positive SCCHN (oral cavity, oropharynx, larynx, or hypopharynx) that is not amenable
to curative therapy (by surgery or radiation with or without chemotherapy).
9. Documentation of p16-positive or p16-negative disease to determine human
papillomavirus (HPV) status of tumor.
10. At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1, minimum 10 mm except lymph nodes (minimum short axis 15 mm). Target lesions
may be in a previously irradiated field if there is documented (radiographic) disease
progression in that site after the completion of radiation therapy.
11. Tumor tissue for PD-L1 testing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1. Subject must have completed or completely discontinued any previous cancer-related treatments before enrollment. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic or hormonal therapy for cancer excludes the subject (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable). The following intervals between the end of the prior treatment and first dose of study drug must be observed:
a) Port-a-cath placement: no waiting is required.
b) Ongoing therapy at a stable dose greater than 2 months duration prior to enrollment and directed to maintaining a stable hormonal milieu (eg, Lupron in prostate cancer subjects) is allowed.
c) Major surgery (as assessed by Investigator) or radiotherapy: = 4 weeks (subjects who receive palliative radiation for non-target tumor lesions need not be subjected to this washout period and can be enrolled immediately).
d) Chemotherapy within 21 days or 5 half-lives (whichever is shorter) from enrollment.
e) Immunotherapy and/or investigational anticancer therapy with agents including monoclonal antibodies = 4 weeks (with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent).
2. History of interstitial lung disease or pneumonitis.
3. Prior therapy with TLR9 agonist, excluding topical agents.
4. Known hypersensitivity to any study drug component.
5. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to study treatment.
6. Prior immune-mediated AE of intensity Grade = 3.
7. Known or suspected autoimmune diseases. Subjects with type I diabetes mellitus or hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Subject with a requirement of systemic steroids should be receiving = 10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study treatment.
8. Subject with another primary malignancy that has not been in remission for at least 3 years except for non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate specific antigen, cervical carcinoma in situ on biopsy, or thyroid cancer (except anaplastic).
9. Active systemic infections requiring antibiotics.
10. Known active hepatitis A, B, or C infections.
11. Known diagnosis of human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).
12. Women who are breast feeding or pregnant.
13. Prior anaphylactic or other severe infusion reaction associated with human antibody administration that cannot be managed by standard supportive measurements.
14. Presence of known central nervous system (CNS), meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if brain metastases are stable for = 4 weeks befor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified