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Cervical CancerPhase 2NCT05033132

A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer

A Phase 2 study testing Balstilimab and Balstilimab + Zalifrelimab in people with Cervical Cancer, run by Agenus Inc. at 43 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label, multi-center Phase II clinical trial to assess the efficacy, safety, and pharmacokinetics of Balstilimab (Treatment Arm 1 - monotherapy) or in combination with Zalifrelimab (Treatment Arm 2 - combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Balstilimab and Balstilimab + Zalifrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
43 sitesChina
Study dates
1 Oct 2021to 30 Dec 2024
Phase
Phase 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 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.
  • Diagnosis:
  • Have a histologically or cytologically confirmed, locally advanced, inoperable and/or metastatic cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma. Note: A pathological report confirmed by histology or cytology of the primary tumor is required for definitive diagnosis. The following cervical tumors are not eligible for inclusion: minimal deviation adenocarcinoma, gastric-type endocervical adenocarcinoma, clear cell adenocarcinoma of the cervix, neuroendocrine carcinoma of the cervix and mesonephric adenocarcinoma.
  • Patients with recurrent/metastatic cervical cancer who have received at least 1 platinum-based systemic therapy (excluding radiosensitizing chemotherapy) (with or without bevacizumab), and experienced recurrence or progression of cervical cancer or were intolerable to chemotherapy toxicity during or after the systemic therapy and were unable to receive radiotherapy or radical surgery again. Note (definition of failure or intolerability of first-line platinum-based chemotherapy):
  • Patients with recurrent or metastatic cervical cancer who have experienced disease progression during platinum-based regimen or have experienced disease progression after receiving ≥4 cycles of effective platinum-based regimen (complete response/progressive disease/stable disease) or were intolerable to toxicity caused by platinum during/after platinum-based regimen and were not suitable for continuous platinum-based regimen.
  • Or
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  • Patients with cervical cancer progressed or relapsed during neoadjuvant or adjuvant chemotherapy with platinum-based regimen (≥4 cycles if the platinum-based regimen is effective) or within 6 months after the end of the treatment, are deemed to have failed first-line platinum-based chemotherapy.
  • Programmed death-ligand 1 (PD-L1) positive (combined positive score ≥1).
  • Have at least 1 measurable lesion on imaging based on RECIST 1.1. Measurable lesions should have not been treated with topical treatment such as radiotherapy. If the only one measurable lesion has been treated with previous topical treatment (radiotherapy, ablation, vascular intervention, etc.), it is necessary to confirm that the lesion has progressed, otherwise it will be recorded as a non-target lesion.
  • Have a life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have satisfactory organ function as indicated by the following laboratory values:
  • Bone marrow: absolute neutrophil count >1.5 × 10^9/liter (L), platelet count >100 × 10^9/L, and hemoglobin >8 grams (g)/deciliter (80 g/deciliter) (without transfusions of blood or blood component within 2 weeks of test);
  • Liver: serum total bilirubin (TBIL) level ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤2.5 × ULN, alanine aminotransferase (ALT) level ≤2.5 × ULN (TBIL ≤1.5 × ULN, AST ≤5 × ULN, ALT ≤5 × ULN in case of presence of liver metastases);
  • Serum creatinine ≤1.5 × ULN; or endogenous creatinine clearance ≥50 milliliters/minute for serum creatinine >1.5 × ULN;
  • Eligible coagulation function, defined as International Normalized Ratio and prothrombin time ≤1.5 x institutional upper limit of normal (IULN); and activated partial thromboplastin time ≤1.5 x IULN.
  • No history of other malignancies within 5 years prior to first dose, except for basal cell carcinoma of the skin, superficial bladder cancer, and squamous cell carcinoma of the skin.
  • Patient must provide an adequate amount of eligible formalin fixed paraffin-embedded tumor tissue samples, preferably from a recent tumor focus biopsy, or tumor tissue samples collected at or after the diagnosis of advanced or metastatic tumors from the site that has not been previously treated with radiation. If tumor tissue is not available, a tumor biopsy is required.
  • Female patients with or without childbearing potential, for the former, the serum pregnancy test should be negative at the time of screening (serum pregnancy test is preferred within 7 days prior to first dose of the investigational drug, otherwise urine pregnancy test is acceptable if serum pregnancy test is not available). Female patients without childbearing potential are defined as follows (for reasons other than medication): ≥45 years of age and menopause for more than 1 year; post hysterectomy, post oophorectomy or post tubal ligation.
  • Females of potential pregnancy must use a highly effective method of contraception (e.g., oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) throughout the study and continue contraception for 12 months after the end of treatment.
  • 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 of 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; experienced major surgical procedures within 4 weeks prior to the first dose.
  • Has received prior therapy with any antibody/drug-targeting T-cell co-stimulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, lymphocyte-activation gene 3, therapeutic vaccines, etc.
  • Have not recovered from the toxicity of their last systemic antineoplastic therapy to grade 1 or below as defined by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5.0 prior to the first dose of the study. Note: Patients with sensory neuropathy or alopecia grade ≤2 are eligible.
  • 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 5.0 Grade ≥3).
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  • Received hematopoietic stimulating factor treatment within 14 days (≤14 days) before the first dose of the study drug, such as granulocyte colony-stimulating factor, erythropoietin, etc.
  • Central nervous system tumors, brain metastases, or meningeal metastases are found prior to the first dose of the study drug. Note: Patients with brain metastases are eligible for the study when meeting the following requirements: brain metastases prove to be stable (patients are required to provide the most recent head imaging prior to the first dose, with previous head imaging at least 4 weeks apart, for the investigator to determine whether the brain metastases are stable by comparing the results of the two examinations); any neurological symptoms resulting from brain metastases or their treatment must have resolved or be maintainable to a minimal degree and the symptoms can be clinically determined to be sequelae of the treated lesion; brain metastases treated with steroids must not be treated with steroids for at least 4 weeks prior to the first dose.
  • Treatment with systemic corticosteroids or any other form of systemic immunosuppression within 7 days (≤7 days) prior to the first dose of the study drug. Note: Combination with corticosteroids for the treatment of immune-related adverse events and prophylactic use of anticontras allergy medications are permitted during the study period; patients requiring daily corticosteroid replacement therapy, e.g., 5 to 7.5 milligrams daily doses of prednisone or equivalent doses of hydrocortisone and steroid therapy (topical, intraocular, intranasal inhalation routes only) may be enrolled in this study. Note: Patients with type 1diabetes, vitiligo, psoriasis, hypothyroidism, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Active autoimmune disease requiring systemic therapy within the past 2 years or history of autoimmune disease or syndrome requiring systemic steroids/immunosuppressive drugs, e.g., hypophysitis, colitis, hepatitis, nephritis, etc. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for renal or pituitary insufficiency) is not considered systemic immunosuppressive therapy. Note: Patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroidism who do not require immunosuppressive therapy are eligible for the study.
  • Has had an allogeneic tissue/solid organ transplant.
  • History of interstitial lung disease or a history of pneumonia that has required oral or intravenous corticosteroids.
  • Symptoms of an active infection requiring intravenous systemic therapy.
  • Positive human immunodeficiency virus antibody or positive syphilis spirochete antibody and positive syphilis spirochete antibody titer test result (i.e., active syphilis infection).
  • Presence of active hepatitis B, hepatitis C or tuberculosis. Active hepatitis B and C are defined as follows: active hepatitis B, positive for hepatitis B surface antigen with the hepatitis B virus deoxyribonucleic acid quantification result greater than the ULN; active hepatitis C, positive for hepatitis C antibody with the hepatitis C virus ribonucleic acid quantification result greater than the ULN.
  • Has clinically significant (i.e., active) cardiovascular disease. Note: The following cases are observed within 6 months prior to the first dose: heart disease (Class III/IV congestive heart failure or heart block as defined by the New York Heart Association); deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmias or angina pectoris; percutaneous coronary intervention, acute coronary syndromes, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Has known mental illness that would interfere with compliance with the requirements of the trial.
  • Has a history of substance abuse, alcoholism or other addictions.
  • Legal incapacity or legal limitation of capacity.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing, Beijing Municipality, 100021

  • Betta Clinical Study Site 25

    Beijing, Beijing Municipality, 100123

  • Betta Clinical Study Site 4

    Bengbu, Anhui, 233004

  • Betta Clinical Study Site 5

    Cangzhou, Hebei, 061001

  • Betta Clinical Study Site 16

    Changchun, Jilin, 130021

  • Betta Clinical Study Site 15

    Changchun, Jilin, 130041

  • Betta Clinical Study Site 6

    Changde, Hunan, 415003

  • Betta Clinical Study Site 36

    Changsha, Hunan, 410008

  • Betta Clinical Study Site 35

    Changsha, Hunan, 410011

  • Betta Clinical Study Site 13

    Changsha, Hunan, 410013

  • Betta Clinical Study Site 42

    Chongqing, Chongqing Municipality, 400030

  • Betta Clinical Study Site 7

    Dalian, Liaoning, 116021

  • Betta Clinical Study Site 9

    Fuzhou, Fujian, 350014

  • Betta Clinical Study Site 38

    Ganzhou, Jiangxi, 341099

  • Betta Clinical Study Site 33

    Hangzhou, Zhejiang, 310009

  • Betta Clinical Study Site 40

    Harbin, Heilongjiang, 150081

  • Betta Clinical Study Site 2

    Hefei, Anhui, 230036

  • Betta Clinical Study Site 3

    Hefei, Anhui, 230601

  • Betta Clinical Study Site 14

    Huizhou, Guangdong, 516001

  • Betta Clinical Study Site 41

    Lanzhou, Gansu, 730000

  • Betta Clinical Study Site 39

    Lanzhou, Gansu, 730099

  • Betta Clinical Study Site 18

    Meizhou, Guangdong, 514031

  • Betta Clinical Study Site 19

    Nanchang, Jiangxi, 330006

  • Betta Clinical Study Site 20

    Nanchang, Jiangxi, 330006

  • Betta Clinical Study Site 21

    Nanjing, Jiangsu, 210008

  • Betta Clinical Study Site 8

    Nanjing, Jiangsu, 210009

  • Betta Clinical Study Site 11

    Nanning, Guangxi, 530021

  • Betta Clinical Study Site 24

    Shangrao, Jiangxi, 334000

  • Betta Clinical Study Site 34

    Shenyang, Liaoning, 110001

  • Betta Clinical Study Site 17

    Shenyang, Liaoning, 110046

  • Betta Clinical Study Site 23

    Taiyuan, Shanxi, 030013

  • Betta Clinical Study Site 26

    Tianjin, Tianjin Municipality, 300000

  • Betta Clinical Study Site 37

    Tianjin, Tianjin Municipality, 300000

  • Betta Clinical Study Site 32

    Ürümqi, Xinjiang, 830011

  • Betta Clinical Study Site 43

    Wuhan, Hubei, 430014

  • Betta Clinical Study Site 28

    Wuhan, Hubei, 430060

  • Betta Clinical Study Site 12

    Wuhan, Hubei, 430070

  • Betta Clinical Study Site 29

    Wuhan, Hubei, 430071

  • Betta Clinical Study Site 27

    Wuhu, Anhui, 241001

  • Betta Clinical Study Site 30

    Xi'an, Shaanxi, 710061

  • Betta Clinical Study Site 22

    Xiamen, Fujian, 361003

  • Betta Clinical Study Site 31

    Xiangyang, Hubei, 441021

  • Betta Clinical Study Site 10

    Zhanjiang, Guangdong, 524001

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase II Study Evaluating Balstilimab Alone or Balstilimab in Combination With Zalifrelimab in Patients With Advanced Cervical Cancer

This is an open-label, multi-center Phase II clinical trial to assess the efficacy, safety, and pharmacokinetics of Balstilimab (Treatment Arm 1 - monotherapy) or in combination with Zalifrelimab (Treatment Arm 2 - combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy.

Conditions
Cervical Cancer
Being tested
Balstilimab, Balstilimab + Zalifrelimab
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.

  • BalstilimabDrug

    Anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody

  • Balstilimab + ZalifrelimabDrug

    An anti-PD-1 monoclonal antibody in combination with a cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody

Study groups in NCT05033132
Study groupRoleWhat they receive
BalstilimabExperimentalBalstilimab monotherapy: approximately 147 patients.
Receives: Drug: Balstilimab
Balstilimab + ZalifrelimabExperimentalBalstilimab in combination with Zalifrelimab (combination therapy): approximately 30 patients.
Receives: Drug: Balstilimab + Zalifrelimab

What is being measured

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

  1. Objective Response Rate (ORR) Of Balstilimab Monotherapy Per Independent Review Committee (IRC) Assessment Based Upon Response Evaluation Criteria In Solid Tumours (RECIST) 1.1

    Measured: 36 months

Secondary outcomes (18)

  1. ORR Of Balstilimab Monotherapy Per Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  2. Disease Control Rate (DCR) Of Balstilimab Monotherapy Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  3. Duration of Response (DOR) Of Balstilimab Monotherapy Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  4. Time to Response (TTR) Of Balstilimab Monotherapy Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  5. Progression-free Survival (PFS) Of Balstilimab Monotherapy Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  6. Overall Survival (OS) Of Balstilimab Monotherapy Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 48 months

  7. ORR Of Combined Therapy Of Balstilimab And Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  8. DCR Of Combined Therapy Of Balstilimab And Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  9. DOR Of Combined Therapy Of Balstilimab And Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  10. TTR Of Combined Therapy Of Balstilimab And Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  11. PFS Of Combined Therapy Of Balstilimab and Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 36 months

  12. OS Of Combined Therapy of Balstilimab And Zalifrelimab Per IRC And Investigator Assessment Based Upon RECIST 1.1

    Measured: 48 months

  13. Peak Plasma Concentration (Cmax) Of Balstilimab And Zalifrelimab

    Measured: Pre-dose (2 hours prior to dosing [dosing to occur every 6 weeks for up to 24 months/17 cycles or until continued disease progression or intolerable toxicity]), End of Treatment

  14. Time To Peak Plasma Concentration (Tmax) Of Balstilimab And Zalifrelimab

    Measured: Pre-dose (2 hours prior to dosing [dosing to occur every 6 weeks for up to 24 months/17 cycles or until continued disease progression or intolerable toxicity]), End of Treatment

  15. Half-life (T1/2) Of Balstilimab And Zalifrelimab

    Measured: Pre-dose (2 hours prior to dosing [dosing to occur every 6 weeks for up to 24 months/17 cycles or until continued disease progression or intolerable toxicity]), End of Treatment

  16. Area Under The Plasma Concentration Versus Time Curve From The Time Of Administration To The Last Measurable Concentration (AUC0-t) Of Balstilimab And Zalifrelimab

    Measured: Pre-dose (2 hours prior to dosing [dosing to occur every 6 weeks for up to 24 months/17 cycles or until continued disease progression or intolerable toxicity]), End of Treatment

  17. Number Of Participants With Anti-drug Antibodies For Balstilimab And Zalifrelimab

    Measured: 36 months

  18. Number Of Participants With Treatment-emergent Adverse Events

    Measured: 48 months

Timeline

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

  1. First posted2 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Why it stopped: Study was never initiated.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05033132
Sponsor's protocol ID
C-750-CN01
Status last verified
Mar 2024
First submitted
27 Aug 2021
Last updated
28 Mar 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Balstilimab and Balstilimab + Zalifrelimab in people with Cervical Cancer, run by Agenus Inc. at 43 sites in China.

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 21 inclusion and 20 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: withdrawn, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. 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 phase mean?

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 was withdrawn before enrolling participants, so there are no results.

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?

Objective Response Rate (ORR) Of Balstilimab Monotherapy Per Independent Review Committee (IRC) Assessment Based Upon Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 (time frame: 36 months). 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 NCT05033132.

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 28 Mar 2024.

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