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Trial Title:
GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05913388
Condition:
Metastatic Melanoma
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Melanoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Conditions: Keywords:
metastatic melanoma
head and neck squamous cell carcinoma
pembrolizumab
galecto
GB1211
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
GB1211
Description:
Administered orally twice daily at 400mg.
Arm group label:
GB1211 + Pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered at a fixed dose of 200 mg every 3 weeks intravenously.
Arm group label:
GB1211 + Pembrolizumab
Arm group label:
Pembrolizumab Monotherapy
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
Placebo
Description:
Administered orally twice daily at 400mg.
Arm group label:
Pembrolizumab Monotherapy
Summary:
The purpose of this study is to determine the objective response of GB1211 and
pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic
melanoma or head and neck squamous cell carcinoma.
Detailed description:
Eligible patients will be registered, stratified by diagnosis (melanoma versus oral, head
and neck (OHN) cancer), and the number of prior systemic therapies, and randomized to
receive either GB1211 + pembrolizumab or pembrolizumab + placebo.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with unresectable or metastatic melanoma including unknown primary or
mucosal melanomas. Histological confirmation of melanoma will be required by
previous biopsy or cytology. Patients with recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC) with disease progression during or after
platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN
cancers.
- Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has
been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other
eligibility criteria and progression of malignancy has been documented on imaging.
Progression for this patient subset is defined as the appearance of one or more new
metastatic sites, or a 5% or greater increase in the sum of diameter of target
lesions or an unequivocal increase in non-target site. Treatment naïve melanoma
patients are eligible.
- Patients must be ≥ 18 years of age.
- ECOG performance status of 0-2.
- Women of childbearing potential must have a serum or urine pregnancy test performed
within 72 hours prior to the start of protocol treatment. The results of this test
must be negative in order for the patient to be eligible. In addition, women of
childbearing potential as well as male patients must agree to take appropriate
precautions to avoid pregnancy.
- No active bleeding.
- Anticipated lifespan greater than 12 weeks.
- Patients must sign a study-specific consent document.
Exclusion Criteria:
- Patients who have previously received a galectin antagonist.
- Patients with active autoimmune disease except for autoimmune thyroiditis or
vitiligo.
- Patients with history of autoimmune colitis.
- Patients with untreated brain metastases. Patients with treated brain metastases who
demonstrate control of brain metastases with follow-up imaging 4 or more weeks after
initial therapy are eligible.
- Patients requiring other systemic oncologic therapy, including experimental
therapies.
- Patients who have received anti-cancer treatment within 3 weeks or 5 half-lives
before first study drug dose.
- Patients with Child-Pugh C hepatic impairment.
- Patients with active infection requiring antibiotics.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
or fetus.
- Need for steroids at greater than physiologic replacement doses. Inhaled
corticosteroids are acceptable.
- Laboratory exclusions (to be performed within 28 days of enrollment):
- WBC < 3.0 x 109/L
- Hgb < 9.0 g/dL
- AST or ALT > 1.5 times ULN
- Total bilirubin > 1.9 g/dL, unless due to Gilbert's Syndrome. If Gilbert's
Syndrome is present by clinical history, then direct bilirubin must by < 3.0
g/dl.
- Active or known history of HIV
- Active or known history of Hepatitis B
- Active or known history of Hepatitis C
- Platelet counts < 100 x 10E9 / L (100,000/ μL) without transfusion
- INR > 1.5x ULN
- Inability to give informed consent and comply with the protocol. Patients must be
judged able to understand fully the investigational nature of the study and the
risks associated with the therapy.
- Any medical condition that in the opinion of the Principal Investigator would
compromise the safety or conduct of the study procedures.
- Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular
enzymes or other toxicities requiring greater than physiological replacement doses
of steroids.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chris Fountain, RN
Phone:
503-215-2691
Email:
Christopher.Fountain@providence.org
Investigator:
Last name:
Brendan D. Curti, MD
Email:
Principal Investigator
Investigator:
Last name:
Rom S. Leidner, MD
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Taylor, MD
Email:
Sub-Investigator
Investigator:
Last name:
William L. Redmond, PhD
Email:
Sub-Investigator
Start date:
February 29, 2024
Completion date:
February 2030
Lead sponsor:
Agency:
Providence Health & Services
Agency class:
Other
Collaborator:
Agency:
Providence Cancer Center
Agency class:
Other
Collaborator:
Agency:
Providence Cancer Center, Earle A. Chiles Research Institute
Agency class:
Other
Collaborator:
Agency:
Galecto Biotech AB
Agency class:
Industry
Source:
Providence Health & Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913388
