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Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)Phase 1/2KEYNOTE-B84NCT04815720

Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 1/2 study testing pepinemab + pembrolizumab in people with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), run by Vaccinex Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
pepinemab + pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
15 sitesUnited States
Study dates
9 Aug 2021to 24 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be ≥18 years of age.
  • Subjects or their legal representative must be able to provide written informed consent to participate in the trial prior to the performance of any study-specific procedures.
  • Subjects must have histologically or cytologically confirmed HNSCC; eligible histologies include SCC of the oropharynx, oral cavity, hypopharynx, and larynx.
  • Subjects must have PD-L1 IHC (including CPS score using an FDA approved test) testing completed within 6 months of screening or at screening.
  • Have measurable disease per RECIST 1.1 as assessed by the central imaging vendor or the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Subjects must have locally advanced, recurrent or metastatic neoplastic disease that is not curable by currently available local therapies.
Show all 25Show fewer
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) PS of 0 or1.
  • Subjects must have a life expectancy of at least 12 weeks.
  • Subjects must have adequate hematologic reserve based on the following:
  • ANC ≥1,500/μL
  • Platelet count >100,000/μL
  • Hemoglobin >9 g/dL
  • Subjects must have adequate hepatic function based on the following:
  • Total bilirubin <1.5 × upper limit of normal (ULN)
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN for subjects with known hepatic metastases).
  • Subjects must have adequate renal function based on the following:
  • Serum creatinine ≤1.5 × ULN; or
  • Calculated creatinine clearance of >30 mL/min.
  • Human immunodeficiency virus (HIV) infected subjects must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
  • Subjects on ART must have a CD4+ T cell count 350 cells/mm3 at time of screening
  • Subjects on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening
  • Subjects on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).
  • Subjects with oropharyngeal cancer must have archival tissue available for p16 testing or be willing to undergo pre-study biopsy to obtain tissue for p16 testing.
  • All subjects must have archival or recently obtained tissue available for biomarker analysis.
  • Female subjects of childbearing potential must have a negative pregnancy test within 72 hours of first dose of study treatment. Female subjects of childbearing potential must use a highly effective mode of contraception or abstain from heterosexual activity for the duration of the trial and for 120 days following the last dose of study medication. A female is NOT of childbearing potential if she has undergone bilateral salpingoophorectomy or is menopausal, defined as an absence of menses for 12 consecutive months. Male subjects must agree to use highly effective contraception.

Who cannot join

  • Subjects with SCC of the nasopharynx.
  • Subjects who have received systemic treatment for recurrent or metastatic HNSCC; however, subjects who have received adjuvant systemic therapy or systemic therapy for locally advanced disease which was completed more than 6 months prior to study enrollment are eligible.
  • Subjects must have recovered from the effects of any prior radiation therapy or surgery.
  • Subjects who have received investigational therapy within 5 half-lives of the investigational agent or 4 weeks, whichever is shorter.
  • Subjects with primary immunodeficiency.
  • Subjects who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥10 mg prednisone daily), cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc.
Show all 30Show fewer
  • Subjects with autoimmune conditions requiring treatment in the previous 2 years; however, subjects on replacement hormonal therapy alone for autoimmune endocrinopathies are eligible for enrollment.
  • Subjects with active central nervous system (CNS) metastases; however, subjects who have undergone radiation and/or surgery for the treatment of CNS metastases, who are neurologically stable and who are no longer taking pharmacologic doses of corticosteroids are eligible; subjects with leptomeningeal metastases are not eligible.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
  • Subjects with a prior malignancy (other than the malignancy under study) in the 2 years prior to enrollment; however, subjects with curatively treated nonmelanoma skin cancers, intra-epithelial cervical neoplasia or in situ carcinoma of the breast are eligible for enrollment.
  • Subjects with prior allogenic transplants.
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  • Subjects with an active infection requiring treatment with systemic antibiotics.
  • Subjects who are pregnant or lactating.
  • Subjects who have received treatment with a prior anti-PD-1 or anti-PD-L1, anti-CTLA-4, or anti-LAG3 agent or who have received prior treatment with pepinemab.
  • HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Subjects who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment.
  • Note: Subjects should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
  • Hepatitis B screening tests are not required unless:
  • Known history of HBV infection
  • As mandated by local health authority.
  • Subjects with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Subjects must have completed curative antiviral therapy at least 4 weeks prior to enrollment.
  • Hepatitis C screening tests are not required unless:
  • Known history of HCV infection
  • As mandated by local health authority.
  • Subjects who have received a live vaccine within 30 days of study enrollment.
  • Current alcohol or drug abuse.
  • Subjects with any intercurrent medical condition where the known risks of participation in the trial outweigh any potential benefits; subjects with psychiatric or social circumstances that preclude responsible participation in the trial; subjects with severe nutritional deficiencies or marked hypoalbuminemia.
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
  • Inability to comply with visit schedule or other protocol requirements.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30308

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718

  • AdventHealth Celebration

    Celebration, Florida, 34747

  • Virginia Cancer Specialists - Fairfax

    Fairfax, Virginia, 22031

  • California Cancer Associates for Research and Excellence (CCARE)-Fresno

    Fresno, California, 93720

  • Northwell Health - Centers for Advanced Medicine

    Lake Success, New York, 11042

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Rochester

    Rochester, New York, 14642

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • Highlands Oncology Group, PA - North Hills

    Springdale, Arkansas, 72762

  • Siteman Cancer Center - Washington University Medical Campus

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Read the detailed description

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study will consist of a safety run in phase and a dose expansion phase.

The primary objective of the Safety Run-in phase of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) for the dose-expansion phase enrolling subjects in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

The primary objective of the Dose Expansion phase of the study is to evaluate objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of the combination of pepinemab/pembrolizumab in immunotherapy naïve patients with R/M HNSCC.

The secondary objectives of the study are to evaluate progression-free survival (PFS) by RECIST 1.1 of the combination of pepinemab/pembrolizumab in immunotherapy naïve patients with R/M HNSCC, to evaluate the overall survival (OS), and to evaluate the duration of response (DOR).

The exploratory objectives of the study are to evaluate PFS, ORR, and DOR via the iRECIST criteria, to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of the combination, to investigate the relationship between treatment with pepinemab and pembrolizumab and certain biomarkers and the genomic signatures of baseline or archival tumor samples.

The Safety Run-in phase will enroll a minimum of 3 subject and a maximum of 18 subjects who will be treated with intravenous pepinemab IV (starting at 20 mg/kg, with potential dose modifications to 15 mg/kg or 10 mg/kg) and pembrolizumab at 200 mg IV, Q3W. The Dose Expansion phase of the study will enroll a maximum of approximately 62 subjects who will be treated with intravenous pepinemab administered IV at the RP2D, plus pembrolizumab 200 mg IV, Q3W.

Subjects will undergo evaluation for extent of disease (EOD) at baseline, week 9, every 6 weeks through year 1, and every 9 weeks thereafter. Subjects who discontinue study treatment will continue to be followed for survival every 12 weeks after safety follow-up (for up to approximately 2 years).

Being tested
pepinemab + pembrolizumab
Keywords
Metastatic, Squamous Cell, Carcinoma, Recurrent, Pepinemab, Pembrolizumab, Head, Neck, VX15/2503, Solid Tumors, Immunotherapy, Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DOR), Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity, Biomarkers, Overall Survival (OS), Extent of Disease (EOD)
Medical subject headings
Recurrence, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pepinemab + pembrolizumabDrug

    Also called KEYTRUDA®

    The Safety Run-in phase will begin at 20 mg/kg pepinemab with a fixed dose of 200 mg pembrolizumab. The dose of pepinemab may be reduced to 15 mg/kg or 10 mg/kg with a fixed dose of 200 mg pembrolizumab if the initial pepinemab dose of 20 mg/kg is found to not be well tolerated. Once a recommended phase II dose of pepinemab is determined it will be utilized in the Dose Expansion phase in combination with 200 mg pembrolizumab.

Study groups in NCT04815720
Study groupRoleWhat they receive
pepinemab + pembrolizumabExperimentalPepinemab will be administered at 20 mg/kg (with possible dose modifications to 15 mg/kg or 10 mg/kg, if the initial 20 mg/kg dose of pepinemab is determined not to be well tolerated) in combination with a fixed dose of 200 mg pembrolizumab, administered in separate IV infusions, Q3W.
Receives: Drug: pepinemab + pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects with Treatment Emergent Adverse Events (TEAE's).

    TEAE's are defined as Adverse Events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IMP but increased in severity or relationship after date-time of first dose of IMP.

    Measured: 2 Years

  2. Evaluation of RP2D

    Review number of subjects with incidence of laboratory abnormalities based on hematology, clinical chemistry, and urinalysis test results with consideration to ECG, vital sign measurements and physical examinations.

    Measured: 2 Years

  3. Efficacy Endpoint

    To be determined by the ORR of the combination pepinemab and pembrolizumab first-line treatment in patients with R/M HNSCC. This is defined as complete response (CR) or PR according to RECIST 1.1 from the first dose until documented confirmed disease progression.

    Measured: 2 Years

Secondary outcomes (13)

  1. Duration of Response (DoR)

    To be measured from the first date of response (CR or PR) until the development of progressive neoplastic disease or death from any cause.

    Measured: 2 Years

  2. Overall Survival (OS)

    To be measured from the date of the first dose (Day 1 of Cycle 1) until death from any cause.

    Measured: 2 Years

  3. Progression Free Survival (PFS)

    To will be measured based on the RECIST 1.1 criteria from the date of enrollment until the development of progressive neoplastic disease or death from any cause.

    Measured: 2 Years

  4. Extent of Disease (EOD)

    To based on radiographic findings on computed tomography (CT) or magnetic resonance imaging (MRI) scan.

    Measured: 2 Years

  5. Pharmacokinetic (PK) Endpoints

    Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-∞).

    Measured: 2 Years

  6. Pharmacokinetic (PK) Endpoints

    AUC from time zero to the time of the last quantifiable concentration (AUC0-tlast).

    Measured: 2 Years

  7. Pharmacokinetic (PK) Endpoints

    Maximum observed plasma concentration (Cmax).

    Measured: 2 Years

  8. Pharmacokinetic (PK) Endpoints

    Time of the maximum observed plasma concentration (tmax).

    Measured: 2 Years

  9. Pharmacokinetic (PK) Endpoints

    Apparent plasma terminal elimination half-life (t1/2).

    Measured: 2 Years

  10. Pharmacokinetic (PK) Endpoints

    Apparent total plasma clearance (CL/F).

    Measured: 2 Years

  11. Pharmacokinetic (PK) Endpoints

    Apparent volume of distribution (Vz/F).

    Measured: 2 Years

  12. Immunogenicity Endpoint

    The incidence and severity of specific antidrug antibodies (ADA) to pepinemab.

    Measured: 2 Years

  13. Pharmacodynamic (PD) Endpoint

    Include receptor occupancy, cellular SEMA4D levels, and total soluble SEMA4D levels.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start9 Aug 2021
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study will be conducted in 2 parts: a Safety Run-in phase and a Dose Expansion phase. The Safety Run-in phase will be based on the starting dose of 20 mg/kg pepinemab and a fixed dose of pembrolizumab (200 mg Q3W); 3 to 6 subjects will be treated at this pepinemab dose level. If the initial 20-mg/kg dose of pepinemab in combination with pembrolizumab is determined not to be well tolerated, the dose of pepinemab will be reduced to 15 mg/kg for an additional 3 subjects and a maximum of 6 subjects and then, potentially, to 10 mg/kg for a third group of 3 subjects and a maximum of 6 subjects. Once the recommended Dose Expansion phase dose is determined, a maximum of approximately 62 subjects will be treated with that dose of pepinemab combined with pembrolizumab.
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04815720
Sponsor's protocol ID
VX15/2503-12
Other IDs
KEYNOTE-B84, MK3475-B84, VX15/2503
Acronym
KEYNOTE-B84
Status last verified
Jan 2025
First submitted
22 Mar 2021
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher TL, Reilly CA, Winter LA, Pandina T, Jonason A, Scrivens M, Balch L, Bussler H, Torno S, Seils J, Mueller L, Huang H, Klimatcheva E, Howell A, Kirk R, Evans E, Paris M, Leonard JE, Smith ES, Zauderer M. Generation and preclinical characterization of an antibody specific for SEMA4D. MAbs. 2016;8(1):150-62. doi: 10.1080/19420862.2015.1102813. Epub 2015 Oct 2.

    PubMed 26431358

  • Dunn GP, Old LJ, Schreiber RD. The immunobiology of cancer immunosurveillance and immunoediting. Immunity. 2004 Aug;21(2):137-48. doi: 10.1016/j.immuni.2004.07.017.

    PubMed 15308095

  • Ribas A. Adaptive Immune Resistance: How Cancer Protects from Immune Attack. Cancer Discov. 2015 Sep;5(9):915-9. doi: 10.1158/2159-8290.CD-15-0563. Epub 2015 Aug 13.

    PubMed 26272491

  • Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, Chmielowski B, Spasic M, Henry G, Ciobanu V, West AN, Carmona M, Kivork C, Seja E, Cherry G, Gutierrez AJ, Grogan TR, Mateus C, Tomasic G, Glaspy JA, Emerson RO, Robins H, Pierce RH, Elashoff DA, Robert C, Ribas A. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27;515(7528):568-71. doi: 10.1038/nature13954.

    PubMed 25428505

  • Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.

    PubMed 26027431

  • Clavijo PE, Moore EC, Chen J, Davis RJ, Friedman J, Kim Y, Van Waes C, Chen Z, Allen CT. Resistance to CTLA-4 checkpoint inhibition reversed through selective elimination of granulocytic myeloid cells. Oncotarget. 2017 Jun 11;8(34):55804-55820. doi: 10.18632/oncotarget.18437. eCollection 2017 Aug 22.

    PubMed 28915554

  • Janssen BJ, Robinson RA, Perez-Branguli F, Bell CH, Mitchell KJ, Siebold C, Jones EY. Structural basis of semaphorin-plexin signalling. Nature. 2010 Oct 28;467(7319):1118-22. doi: 10.1038/nature09468. Epub 2010 Sep 26.

    PubMed 20877282

  • Tamagnone L, Artigiani S, Chen H, He Z, Ming GI, Song H, Chedotal A, Winberg ML, Goodman CS, Poo M, Tessier-Lavigne M, Comoglio PM. Plexins are a large family of receptors for transmembrane, secreted, and GPI-anchored semaphorins in vertebrates. Cell. 1999 Oct 1;99(1):71-80. doi: 10.1016/s0092-8674(00)80063-x.

    PubMed 10520995

  • Ch'ng ES, Kumanogoh A. Roles of Sema4D and Plexin-B1 in tumor progression. Mol Cancer. 2010 Sep 21;9:251. doi: 10.1186/1476-4598-9-251.

    PubMed 20858260

  • Younis RH, Han KL, Webb TJ. Human Head and Neck Squamous Cell Carcinoma-Associated Semaphorin 4D Induces Expansion of Myeloid-Derived Suppressor Cells. J Immunol. 2016 Feb 1;196(3):1419-29. doi: 10.4049/jimmunol.1501293. Epub 2016 Jan 6.

    PubMed 26740106

  • Chen Y, Zhang L, Lv R, Zhang WQ. Overexpression of Semaphorin4D indicates poor prognosis and prompts monocyte differentiation toward M2 macrophages in epithelial ovarian cancer. Asian Pac J Cancer Prev. 2013;14(10):5883-90. doi: 10.7314/apjcp.2013.14.10.5883.

    PubMed 24289594

  • Ch'ng E, Tomita Y, Zhang B, He J, Hoshida Y, Qiu Y, Morii E, Nakamichi I, Hamada K, Ueda T, Aozasa K. Prognostic significance of CD100 expression in soft tissue sarcoma. Cancer. 2007 Jul 1;110(1):164-72. doi: 10.1002/cncr.22764.

    PubMed 17520683

  • Clavijo PE, Friedman J, Robbins Y, Moore EC, Smith E, Zauderer M, Evans EE, Allen CT. Semaphorin4D Inhibition Improves Response to Immune-Checkpoint Blockade via Attenuation of MDSC Recruitment and Function. Cancer Immunol Res. 2019 Feb;7(2):282-291. doi: 10.1158/2326-6066.CIR-18-0156. Epub 2018 Dec 4.

    PubMed 30514791

  • Evans EE, Jonason AS Jr, Bussler H, Torno S, Veeraraghavan J, Reilly C, Doherty MA, Seils J, Winter LA, Mallow C, Kirk R, Howell A, Giralico S, Scrivens M, Klimatcheva K, Fisher TL, Bowers WJ, Paris M, Smith ES, Zauderer M. Antibody Blockade of Semaphorin 4D Promotes Immune Infiltration into Tumor and Enhances Response to Other Immunomodulatory Therapies. Cancer Immunol Res. 2015 Jun;3(6):689-701. doi: 10.1158/2326-6066.CIR-14-0171. Epub 2015 Jan 22.

    PubMed 25614511

  • Leonard JE, Fisher TL, Winter LA, Cornelius CA, Reilly C, Smith ES, Zauderer M. Nonclinical Safety Evaluation of VX15/2503, a Humanized IgG4 Anti-SEMA4D Antibody. Mol Cancer Ther. 2015 Apr;14(4):964-72. doi: 10.1158/1535-7163.MCT-14-0924. Epub 2015 Feb 5.

    PubMed 25657333

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pepinemab + pembrolizumab in people with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), run by Vaccinex Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects with Treatment Emergent Adverse Events (TEAE's). (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04815720, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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