BelieveIT-201: A Randomized, Phase 2, Open-label Trial of TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 B/y, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives

To evaluate MPR of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ as compared with pembrolizumab monotherapy

Secondary Objectives

To evaluate the anti-tumor activity of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ as compared with pembrolizumab monotherapy
To evaluate the safety and tolerability of TransCon TLR7/8 Agonist in combination with pembrolizumab and TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ

Eligibility

Inclusion Criteria:

At least 18 years of age
Demonstrated adequate organ function at screening
Life expectancy >12 weeks as determined by the Investigator
Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the neoadjuvant cohorts
Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
Part 3: Neoadjuvant cohorts: participants must have completely resectable disease

Exclusion Criteria:

Symptomatic central nervous system metastases and/or carcinomatous meningitis
Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
Any uncontrolled bacterial, fungal, viral, or other infection
Significant cardiac disease
A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using Fridericia's QT correction formula
Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C infection
Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
Part 3, Post Anti-PD-1 Melanoma, 2L+ Cervical Cancer, and Neoadjuvant Melanoma: Participants who have been previously treated with IL-2 or IL-2 variants (all participants), or TLR agonist
Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
Vaccination with live, attenuated vaccines within 4 weeks of C1D1
Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
Part 3: Other active malignancies within the last 2 years
Women who are breastfeeding or have a positive serum pregnancy test during screening

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices