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Study of NEO-201 with pembrolizumab for solid tumors

This study is testing a combination of two drugs, NEO-201 and pembrolizumab, for people with advanced non-small cell lung cancer, head and neck squamous cell carcinoma, cervical cancer, or uterine cancer that has progressed after initial treatment. NEO-201 is an experimental monoclonal antibody (a type of targeted therapy) and pembrolizumab is a checkpoint inhibitor (a type of immunotherapy). The study aims to see how safe this combination is and how well it shrinks tumors or stops them from growing. You would receive NEO-201 intravenously (into a vein) every two weeks and pembrolizumab every six weeks.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving) study with a planned enrollment of 121 participants.
What's involved
You would receive NEO-201 intravenously every two weeks and pembrolizumab every six weeks. The study will assess safety and tumor response over 1.5 years.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and tumor response for 1.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03476681

Study of NEO-201 in Solid Tumors Expansion Cohorts

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Precision Biologics, Inc
~121 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:NEO-201 in combination with pembrolizumab

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the safety of the combination of NEO-201 with pembrolizumab the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured over 1.5 years
+2 more outcomes measured

Conditions

Non Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Uterine Cancer

Explore related trials

Cervical CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Uterine NeoplasmMonoclonal Antibody NEO-201

Where it's being run

2 sites across 2 states
Maryland1
Virginia1

Study leadership

  • Stan Lipkowitz, MD · PRINCIPAL_INVESTIGATOR · National Cancer Institute - Women's Malignancy Branch

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: \>/=18 years
Diagnosis:
Subjects must have histologically or cytologically confirmed recurrent, locally advanced unresectable or metastatic cancer confirmed by the Laboratory of Pathology, NCI
Subjects enrolled in the expansion cohorts must have advanced non-small cell lung cancer, HNSCC, uterine cancer, or cervical cancer that has progressed during or after at least one front-line standard of care treatment, including chemotherapy and/or targeted therapy
Tumor is positive for NEO-201 antigen expression (defined as at least 10% of tumor cells expressing NEO-201 target antigen).
Patient is not a candidate for potentially curative surgery or radiation.
Tumor(s) must express PD-L1 (TSP \> 1%) as determined by an FDA-approved test and/or is microsatellite instability-high (MSI-H) or mismatch repair deficient, and/or is tumor mutational burden-high (TMB-H) \[≥10 mutations/megabase (mut/Mb)\], as determined by an FDA-approved test.
Patients with EGFR, ALK1, ROS1 or BRAF V600E genomic tumor aberrations must have had disease progression on FDA-approved agents for these aberrations.
Patients without these genomic tumor aberrations must have received immune-checkpoint inhibitor previously, either as a single agent or in combination with chemotherapy.
Must have archived tissue (10 unstained slides or tissue block), or must have tumor which can be safely biopsied percutaneously and be willing to undergo a tumor biopsy
MEASURABLE/EVALUABLE DISEASE: Measurable disease (by RECISTv1.1)
INFORMED CONSENT: Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
PERFORMANCE STATUS: ECOG ≤ 2; or Karnofsky performance status of ≥ 50%
LABORATORY FUNCTION:
Screening laboratory data within 21 days of the first dose of study drug. Subject must have adequate organ function:
Hemoglobin \> 9 g/dL, or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication
Absolute neutrophil count (ANC) ≥1,500/mm3
Platelets ≥ 100,000/mm3
Total bilirubin ≤ 2.0 mg/dL
ALT and AST ≤ 3 times the ULN, or, if the subject has liver metastases, ≤ 5 times the ULN
Creatinine ≤ 1.5 mg/dL or creatinine clearance \> 40 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula
PRIOR THERAPY:
At least 14 days must have elapsed since treatment with oral tyrosine kinase inhibitors, or until toxicities associated with TKI therapy have resolved
At least 21 days must have elapsed since treatment with previous monoclonal antibodies, or until toxicities associated with mAb therapy have resolved
At least 4 weeks must have elapsed since any chemotherapeutic agents at the time of enrollment (or 6 weeks for regimens containing BCNU or mitomycin C)
At least 2 weeks must have elapsed since any systemic corticosteroids at the time of enrollment
Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines.
XRT: At least 7 days after local palliative XRT (small port)
Subjects must have recovered from any acute toxicity related to prior therapy, except for alopecia. Toxicity should be ≤ grade 1, or ≤ grade 2 for peripheral neuropathy, or hypothyroidism
Subject is expected to be able to remain on a study protocol for at least 8 weeks
BIRTH CONTROL: Female subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study, and 2 weeks after completion of NEO-201 administration or 4 months after the last dose of pembrolizumab (according to package labeling), whichever is later.

Exclusion

History of disseminated or uncontrolled brain metastases or central nervous system disease. Brain metastases will be considered controlled if SD on two consecutive brain MRIs, performed at least 2 months apart, and subject is without seizures.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to NEO-201 or other agents used in this study.
Any major surgery within 14 days of enrollment.
Receiving any other investigational agents.
No archival tissue available and a lesion(s) that cannot be safely biopsied via percutaneous route, or is unwilling to undergo biopsy.
Has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, hypokalemia, family history of Long QT Syndrome or presence of cardiac arrhythmia.
Subjects who are assessed to have unacceptable risk of developing infection from neutropenia will be excluded at the Investigator's discretion.
HIV-positive subjects on combination antiretroviral therapy are ineligible because of the unknown potential for pharmacokinetic interactions with NEO-201. In addition, these subjects are at increased risk of lethal infections which could complicate the toxicity assessment of this study. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.
Subject has other serious medical illness, including a second malignancy, or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Pregnant women are excluded from this study because the potential for teratogenic or abortifacient effects due to NEO-201 is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NEO-201, breastfeeding should be discontinued if the mother is treated with NEO-201.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to start of study therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Subjects who experienced severe or life-threatening immune-related AEs with prior immune checkpoint therapy requiring medical intervention (steroid or immunosuppressant drugs) and permanent discontinuation of therapy, will be excluded. These include, but not limited to colitis, autoimmune hepatitis, hypophysitis, hyperthyroidism, nephritis, myocarditis, GBS, encephalitis.

What this trial measures

  • Determine the safety of the combination of NEO-201 with pembrolizumab the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.1.5 years

    To evaluate toxicity a safety lead in of 3 to 6 subjects will be conducted. The safety lead in will be 42 days long, consisting of 3 doses of NEO-201 and 1 dose of pembrolizumab followed by a 2 week assessment. All appropriate treatment areas will have access to a the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.

  • Determine Objective Response Rate (either Complete Response or Partial Response) as determined by RECIST v1.1 guidelines1.5 years

    For the purposes of this study, subjects will be re-evaluated for response every 12 weeks. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

  • Determine Progression Free Survival as determined by RECIST v1.1 guidelines1.5 years

    For the purposes of this study, subjects will be re-evaluated for progression every 12 weeks. Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.