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Advanced CancerPhase 1/2NCT03104699

A Study of AGEN2034 in Advanced Tumors and Cervical Cancer

A Phase 1/2 study testing AGEN2034 in people with Advanced Cancer and Cervical Cancer, run by Agenus Inc. at 44 sites in 9 countries.

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

This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Cancer, Cervical Cancer
What is being tested?
AGEN2034
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
44 sitesin 9 countries
Study dates
11 Apr 2017to 15 Jun 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional.
  • Be ≥18 years of age.
  • Diagnosis and prior systemic treatment:
  • Phase 1: Have a histologically or cytologically confirmed diagnosis of a metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed.
  • Phase 2: I. Have (1) a histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) metastatic, locally advanced, and/or unresectable disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report. Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma. II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease; Note: Participants who have received >1 prior systemic treatment regimen for their advanced or metastatic disease will be eligible in the following cases: Participant receiving chemotherapy concurrently with primary radiation (for example, weekly cisplatin) or participant receiving adjuvant chemotherapy following completion of radiation therapy (for example, paclitaxel and carboplatin for ≤4 cycles) and progressed within 6 months after treatment completion.
  • Measurable disease - based on investigator assessment
Show all 26Show fewer
  • Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.
  • Phase 2: Have measurable disease on imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Note: Participants must have at least one "target lesion" to be used to assess response, as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Participants without centrally confirmed measurable disease at baseline will not be eligible for this trial.
  • Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have adequate organ function as indicated by the following laboratory values:
  • Adequate hematological function defined by absolute neutrophil count ≥1.5 x 10^9/liter (L), platelet count ≥100 x 10^9/L, and stable hemoglobin ≥8 grams/deciliter (without transfusions within 1 week before first dose).
  • Adequate hepatic function based by a total bilirubin level ≤ the institutional upper limit of normal (IULN), aspartate aminotransferase level ≤2.5 x IULN, alanine aminotransferase level ≤2.5 x IULN, and alkaline phosphatase ≤2.5 x IULN.
  • Adequate renal function defined as creatinine ≤1.5 x IULN or calculated creatinine clearance ≥50 milliliters/minute for participants with creatinine levels >1.5 x IULN (if no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).
  • Adequate coagulation defined by international normalized ratio or prothrombin time ≤1.5 x IULN (unless the participant is receiving anticoagulant therapy); and activated partial thromboplastin time ≤1.5 x IULN (unless the participant is receiving anticoagulant therapy)
  • Other than the cancer for which the participant is enrolled, have no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous-cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • In Phase 2, participants must provide a sufficient and adequate formalin-fixed paraffin-embedded tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required.
  • Note: Tissue from needle or excisional biopsy or from resection is required.
  • Female participants must have a negative serum pregnancy test at screening (within 72 hours before first dose of study drug) if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
  • ≥45 years of age and has not menstruated for greater than 1 year,
  • Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation,
  • Whose status is post hysterectomy, oophorectomy or tubal ligation.
  • If of childbearing potential, female participants must be willing to use 2 highly effective methods (defined in the informed consent form [ICF]) throughout the study, starting with the screening visit through 120 days after the last dose of study treatment.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
  • Male participants with a female partner(s) of childbearing potential must agree to use 2 highly effective methods (defined in the ICF) throughout the trial starting with the screening visit through 120 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
  • Is willing and able to comply with the requirements of the protocol.

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks before the first dose of treatment.
  • Has an inadequate washout period prior to first dose of study drug defined as:
  • Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
  • Received radiation therapy within 3 weeks before first dose, or
  • Had major surgery within 4 weeks before first dose.
  • Has received prior therapy with:
Show all 26Show fewer
  • Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-programmed cell death ligand 1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies
  • For Phase 2: >1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the participant is considered for the study Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for participants with metastatic melanoma.
  • Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE) Grade >1 severity.
  • Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.
  • Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
  • Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI CTCAE Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.
  • Is receiving systemic corticosteroid ≤7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events, and/or a premedication for IV contrast allergies/reactions is allowed). Participants who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.
  • Has a central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent. Note: Participants with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥7 days prior to first dose of study drug.
  • Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment (that is, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (that is, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Note: Participants with type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has or had interstitial lung disease or has had a history of pneumonitis that has required oral or IV corticosteroids.
  • Has an active infection requiring intravenous systemic therapy.
  • Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B, Hepatitis C or tuberculosis. Active Hepatitis B is defined as a known positive Hepatitis B surface antigen result. Active Hepatitis C is defined by a known positive Hepatitis C antibody result and known quantitative Hepatitis C virus ribonucleic acid results greater than the lower limits of detection of the assay.
  • Has clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
  • Is legally incapacitated or has limited legal capacity.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment.

Trial locations and contacts

44 sites in 9 countries.

44 sites in 9 countries

United States12 sites

  • Augusta Oncology

    Augusta, Georgia, 30912

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California - Keck School of Medicine

    Los Angeles, California, 90033

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists & Research Institute

    Sarasota, Florida, 34232

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Swedish Medical Center-Cherry Hill Campus

    Seattle, Washington, 98104

Other trials in United States

France11 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Léon Bérard

    Lyon, 69008

  • L'Institut Paoli - Calmettes

    Marseille, 13273

  • CHU Hôpital de la Timone

    Marseille, 13385

  • Centre Antoine-Lacassagne

    Nice, 6189

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon

    Paris, 75020

  • Clinique Armoricaine de Radiologie

    Plérin, 22190

  • Institute de Cancerologie de l'Ouest (ICO) - René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31100

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Brazil7 sites

  • Hospital de Caridade de Ijuí

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • IMIP

    Recife, Pernambuco, 50070-550

  • Instituto Nacional de Câncer

    Rio de Janeiro, Rio de Janeiro, 20220-410

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000

  • Instituto do Cancer do Estado de São Paulo

    São Paulo, São Paulo, 01246-000

  • Hospital Amaral Carvalho

    São Paulo, São Paulo, 03162-065

Other trials in Brazil

Chile4 sites

  • Centro Oncológico del Norte

    Antofagasta, AN, 1240000

  • Fundación Arturo López Pérez

    Santiago, RM, 7500918

  • Bradford Hill

    Santiago, RM, 8420323

  • Centro De Investigación Del Cancer James Lind

    Temuco, AR, 4800827

Other trials in Chile

Spain3 sites

  • Vall d'Hebron Institut d'Oncologia

    Barcelona, 8035

  • Hospital Clínic de Barcelona

    Barcelona, 8036

  • Clínica Universidad de Navarra

    Madrid, 28027

Other trials in Spain

Australia2 sites

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 5006

Other trials in Australia

Estonia2 sites

  • East-Tallinn Central Hospital

    Tallinn, 1131

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

Poland2 sites

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, Pomeranian Voivodeship, 81-519

  • Szpital Swietego Rafala w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-693

Other trials in Poland

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: A Phase 1/2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion to Second Line Cervical Cancer

This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen.

Read the detailed description

Phase 1: Dose Escalation

Phase 1 will consist of a standard 3+3 dose escalation with the following escalating dose levels and schedules:

Part A1: 1, 3, and 10 milligrams/kilogram (mg/kg) administered every 2 weeks

Part A2: 6 and 10 mg/kg every 3 weeks

Each participant will stay on the dose level and schedule assigned at trial entry. Participants will receive AGEN2034 for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

A Safety Monitoring Committee (SMC) will assess safety; decide on dose-escalation and opening of backfill enrollment; define the recommended Phase 2 dose (RP2D); and determine opening of the Phase 2 cohorts.

In Part A1, the first participant of each cohort will be observed for 16 days (that is, ≥48 hours after second dose) for occurrence of dose-limiting toxicity (DLT) before the second participant is administered trial medication. Thereafter, within each cohort, consecutively enrolled participants may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or the maximum planned dose level (10.0 mg/kg) is shown to be safe. The MTD is defined as the dose below which ≥2 DLTs are observed.

Once Part A1 is completed, enrollment to Part A2 will begin. If <2 DLTs are observed in Part A1 at the maximum planned dose of 10 mg/kg every 2 weeks, open enrollment to Part A2 will begin with enrollment of 10 participants at 6 mg/kg every 3 weeks, followed by open enrollment of 10 participants at 10 mg/kg every 3 weeks. If ≥2 DLTs are observed in Part A1, at the maximum planned dose in Part A1, the standard 3+3 dose escalation will resume with Part A2 where consecutively enrolled participants in dose escalation may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment.

For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional participants will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 participants. Participants enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (that is, not required to wait 48 hours between 2 participants). These additional participants at each dose level will have the purpose of generating additional safety, pharmacokinetics, and receptor occupancy data, and will not undergo formal DLT observation.

Phase 2: Dose Expansion

To further characterize safety and efficacy, participants with recurrent, unresectable, or metastatic cervical cancer will be enrolled in Phase 2 and receive the RP2D of AGEN2034 (3 mg/kg every 2 weeks) for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

An SMC will assess safety, and an Independent Data Monitoring Committee will evaluate safety and efficacy.

Being tested
AGEN2034
Keywords
Antibodies, Immunologic effects, Physiological Effects of Drugs
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • AGEN2034Drug

    Also called Anti-PD-1

    Anti-programmed cell death protein-1 (PD-1) Monoclonal Antibody

Study groups in NCT03104699
Study groupRoleWhat they receive
MonotherapyExperimentalDose of 3 mg/kg intravenous (IV) every 2 weeks for up to 24 months.
Receives: Drug: AGEN2034

What is being measured

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

  1. Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab

    A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).

    Measured: 21 days

  2. Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.

    Measured: Up to 3 years

  3. Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)

    ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 3 years

Secondary outcomes (15)

  1. Phase 1: Receptor Occupancy of Circulating T Cells

    The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness.

    Measured: 4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)

  2. Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab

    Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL).

    Measured: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)

  3. Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab

    Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours*micrograms/milliliter (h*µg/mL).

    Measured: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)

  4. Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab

    Blood samples were collected for serum balstilimab ADA determination.

    Measured: Up to 2.5 years

  5. Phase 2: Number of Participants Experiencing TEAEs

    An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 3 years

  6. Phase 2: Cmax of Balstilimab

    Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL.

    Measured: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)

  7. Phase 2: AUC0-last of Balstilimab

    Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day*μg/mL.

    Measured: Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)

  8. Phase 2: Number of Participants With Serum ADAs for Balstilimab

    Blood samples were collected for serum balstilimab ADA determination.

    Measured: Up to 2.5 years

  9. Phase 2: ORR as Determined by the Investigator

    ORR was defined as percentage of participants with a BOR of CR or PR, as determined by the investigator per RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 3 years

  10. Phase 2: Duration of Response (DOR)

    DOR was defined as time from first observation of response to first observation of documented progressive disease (PD) (or death within 12 weeks after last tumor assessment), per RECIST 1.1 and as determined by an IERC and the investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.

    Measured: Up to 3 years

  11. Phase 2: Disease Control Rate (DCR) as Determined by an IERC

    DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) for at least 12 weeks. CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).

    Measured: Up to 3 years

  12. Phase 2: Tumor Control Rate (TCR) as Determined by an IERC

    TCR was defined as percentage of participants who had a BOR of either SD or a confirmed objective response (CR or PR). CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).

    Measured: Up to 3 years

  13. Phase 2: Time to Response (TTR) as Determined by an IERC

    TTR was defined as the time from the first dose date to first observation of confirmed response.

    Measured: Up to 3 years

  14. Phase 2: Progression-free Survival (PFS)

    PFS was defined as time from first treatment administration to first observation of documented PD (or death within 12 weeks after last tumor assessment), per RECIST 1.1, as determined by an IERC and investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.

    Measured: Up to 3 years

  15. Phase 2: Overall Survival (OS)

    OS was defined as time from start of treatment to death. For participants who were still alive at the time of data cutoff for trial analysis or who were lost to follow-up, survival was censored at the last recorded date that the participant was known to have been alive as of the cutoff date for analysis.

    Measured: Up to 3 years

Timeline

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

  1. First posted7 Apr 2017
  2. Study start11 Apr 2017
  3. Primary completion15 Jun 2022
  4. Study completion15 Jun 2022

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
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104699
Sponsor's protocol ID
C-700-01
Status last verified
Jul 2025
First submitted
27 Mar 2017
Last updated
30 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AGEN2034 in people with Advanced Cancer and Cervical Cancer, run by Agenus Inc. at 44 sites in 9 countries.

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 26 inclusion and 26 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, France, Brazil, Chile, Spain and 4 more countries. 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?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab (time frame: 21 days). 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 NCT03104699.

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 30 Jul 2025.

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