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Cervical CancerPhase 2CQGOG0101NCT04395612

Niraparib Combined With Brivanib or Toripalimab in Patients With Cervical Cancer

A Phase 2 study testing niraparib combined with brivanib and niraparib combined with toripalimab in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and Persistent Cervical Cancer Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
niraparib combined with brivanib and niraparib combined with toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
8 May 2020to 1 Jul 2022
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, aged ≥ 18 yrs and ≤70 yrs;
  • Patients volunteered to participate in this study, signed informed consent, good compliance, and cooperated with follow-up;
  • The subjects' damage caused by other treatments has been recovered (NCI CTCAE version 5.0 grade ≤ grade 1), ECOG score ≤ 2 points
  • Expected survival is longer than 3 months;
  • Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma;
  • Evaluable lesions: CT scan of tumor lesions ≥5mm in length, CT scan of lymph node lesions ≥10mm in length, and scan layer thickness not greater than 5mm (refer to RECIST 1.1);
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  • The first diagnosis was confirmed by pathology and / or cytology to be metastatic, or recurrent, persistent cervical cancer (mainly refers to tumors remaining or progressing at least 3 months after initial radiotherapy or concurrent chemoradiotherapy), and the patient can no longer accept Surgery or chemoradiation;
  • Subject agrees to take blood sample;
  • Subjects can provide formalin-fixed, paraffin-embedded tumor tissue samples for subsequent related gene testing (optional);
  • A.Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.0×109/L ; platelets >=100×109/L B. Biochemical test standards: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 times the upper limit of normal value (ULN). If with liver metastases, ALT and AST ≤ 5 × ULN; b. Total bilirubin (TBIL) ≤ 1.5 × ULN; c. Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60ml / min; d. Doppler ultrasound evaluation: left ventricular ejection Blood fraction (LVEF) ≥ the lower limit of normal value (50%).
  • Women of childbearing age should agree that contraception (such as an intrauterine device, contraceptive, or condom) must be used during the study and within 3 months after the last dose; a serum or urine pregnancy test must be negative within 14 days of study enrollment and must be Non-lactating patients. Sign written informed consent before conducting any research-related procedures.

Who cannot join

  • 1.People who are known to be allergic to zl-2306 (niraparib)，brivanib and toripalimab or to active or inactive ingredients of drugs with similar chemical structures to zl-2306 (niraparib），brivanib and toripalimab.
  • 2.Multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, etc.).
  • 3.Symptomatic, uncontrolled brain metastases or pia meningeal metastases. No imaging scan is required to confirm brain-free metastases; patients with spinal cord compression may still be considered if they have received targeted treatment and have evidence of clinical stability of the disease for at least> 28 days (controlled central nervous system metastasis must be in the study Have received treatment such as radiation or chemotherapy for at least 1 month; patients must not have new symptoms related to central nervous system lesions or symptoms that indicate disease progression, and patients either take a stable dose of hormones or do not need to take hormones).
  • 5.Underwent major surgery within 3 weeks before the study began, or any surgical effects that have not recovered after surgery, or received chemotherapy.
  • 6.Received> 20% bone marrow palliative radiotherapy 1 week before enrollment. 7.Have aggressive cancers other than cervical cancer (except fully treated basal or squamous cell skin cancer within 2 years before enrollment).
  • 8.Patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
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  • 9.Suffering from a serious or uncontrolled illness, including but not limited to:
  • Uncontrollable nausea and vomiting, inability to swallow research drugs, and any gastrointestinal disorders that may interfere with the metabolism of the drug.
  • Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.
  • Uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental illnesses that prevent patients from signing informed consent.
  • Immunodeficiency (except splenectomy), or other diseases that the investigator believes may expose patients to high-risk toxicity.
  • 10.History of bleeding and thrombosis:
  • <!-- -->
  • Any CTCAE Grade 2 bleeding event within 3 months prior to screening, or CTCAE Grade 3 and above bleeding events within 6 months prior to screening.
  • History of gastrointestinal bleeding or clear gastrointestinal bleeding tendency within 6 months before screening. Such as: esophageal varices at risk of bleeding, focal lesions of locally active ulcers, or fecal occult blood +.
  • Have active bleeding or coagulopathy, have a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.
  • Patients need anticoagulation with drugs such as warfarin or heparin.
  • Patients need long-term antiplatelet therapy (eg aspirin, clopidogrel).
  • Thrombosis or embolism events in the past 6 months, such as: cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism.
  • 11.Serious cardiovascular history:
  • <!-- -->
  • NYHA (New York Heart Association) Grade 3 and 4 congestive heart failure.
  • Suffering from unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening.
  • Arrhythmias requiring therapeutic intervention (patients taking beta-blockers or digoxin can be enrolled).
  • CTCAE≥ grade 2 valvular heart disease.
  • 12.Poorly controlled hypertension (systolic blood pressure> 150 mmHg or diastolic blood pressure> 100 mmHg).
  • 13.Other laboratory inspection abnormalities:
  • <!-- -->
  • Hyponatremia (sodium <130 mmol / L); baseline serum potassium <3.5 mmol / L (before entering the study, potassium supplements can be used to restore serum potassium above this level).
  • Abnormal thyroid function, and drugs cannot maintain thyroid function within normal range.
  • 14.Any previous or current disease, treatment, or laboratory abnormality that may interfere with the results of the study, affect the patient's full participation in the study, or the investigator believes that the patient is not suitable to participate in the study; the patient may not receive platelets within 4 weeks before the study drug begins Red blood cell infusion.
  • 15.Patients who are pregnant or breastfeeding, or plan to become pregnant during study treatment.
  • 16.Corrected QTc interval (QTc)> 450 milliseconds; if the patient has a prolonged QTc interval, but the investigator evaluates that the reason for the prolongation is a pacemaker (and no other cardiac abnormalities), it is necessary to discuss with the investigator to determine whether the patient is suitable Group study.
  • 17.With any active autoimmune disease or have a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or asthma has been completely relieved in childhood and do not need any intervention after adulthood could be included; Asthma patient who need bronchodilators for medical intervention cannot be included) 18.Treatment with other immunosuppressive medications, systemic or topical corticosteroids (>10 mg daily prednisone or equivalent) within 14 days before enrollment.
  • 19.With a history of severe allergic reaction to other monoclonal antibodies 20.Evidence of central nervous system metastasis (such as brain edema requiring hormone intervention, or brain metastasis progression). Patients who have previously received treatment for brain or meningeal metastasis and persistently stable (MRI) for at least 1 month thus stopped systemic hormone therapy (dose > 10mg/ prednisone or other therapeutic hormones) for more than 2 weeks can be included.
  • 21.Have previously received any PARP inhibitor or PD-1/PD-L1 inhibitor treatment.

Trial locations and contacts

1 site in 1 country.

Qi Zhou, Ph.D. contact

13708384529

qizhou9128@163.com

China1 site, 1 recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Qi Zhou, PhD, qizhou9128@163.com

    Qi Zhou, PhD

    Recruiting

Other trials in China

About this study

Official title: A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and Persistent Cervical Cancer

A Clinical Proof-of-concept Study Evaluating Efficacy and Safety of ZL-2306 (Niraparib) Combined With Brivanib or Toripalimab in Patients With Metastatic, Recurrent, and Persistent Cervical Cancer

Read the detailed description

A prospective, open-ended, single-arm, phase II clinical study.Patients are with metastatic, recurrent, persistent cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) To observe the efficacy and safety of ZL-2306 (Niraparib) combined with Brivanib or Toripalimab in patients with metastatic, recurrent and persistent cervical cancer, and to explore the biomarkers of effectiveness.

Conditions
Cervical Cancer
Being tested
niraparib combined with brivanib, niraparib combined with toripalimab
Keywords
Cervical Cancer,Niraparib,Brivanib,Toripalimab
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.

  • niraparib combined with brivanibDrug

    Also called Treatment group1

    Drug：Niraparib will be administered as a dose of 200 mg orally every day. Drug：Brivanib will be administered as a dose of 400mg orally every day.

  • niraparib combined with toripalimabDrug

    Also called Treatment group2

    Drug：Niraparib will be administered as a dose of 200 mg orally every day. Drug：Toripalimab will be administered as a dose of 240mg Intravenously every 21days.

Study groups in NCT04395612
Study groupRoleWhat they receive
Treatment arm1Experimentalniraparib 200mg/day and brivanib 400mg/day
Receives: Drug: niraparib combined with brivanib
Treatment arm2Experimentalniraparib 200mg/day and toripalimab 240mg/21 days
Receives: Drug: niraparib combined with toripalimab

What is being measured

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

  1. ORR

    Objective To evaluate the objective response rate (CR + PR) of ZL-2306 (niraparib) combined with brivanib or toripalimab in patients with relapsed and persistent cervical cancer.

    Measured: 6 months

Secondary outcomes (2)

  1. PFS

    progression-free survival

    Measured: 6 months

  2. DCR

    evaluate the safety of combined application of ZL-2306 (niraparib) combined with brivanib or toripalimab， disease control rate

    Measured: 6 months

Timeline

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

  1. First posted20 May 2020
  2. Study start8 May 2020
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395612
Sponsor's protocol ID
CQGOG0101
Acronym
CQGOG0101
Status last verified
Mar 2021
First submitted
23 Apr 2020
Last updated
21 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.

    PubMed 27717299

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PubMed 25651787

  • Chen WQ, Li H, Sun KX, Zheng RS, Zhang SW, Zeng HM, Zou XN, Gu XY, He J. [Report of Cancer Incidence and Mortality in China, 2014]. Zhonghua Zhong Liu Za Zhi. 2018 Jan 23;40(1):5-13. doi: 10.3760/cma.j.issn.0253-3766.2018.01.002. Chinese.

    PubMed 29365411

  • Eskander RN, Tewari KS. Immunotherapy: an evolving paradigm in the treatment of advanced cervical cancer. Clin Ther. 2015 Jan 1;37(1):20-38. doi: 10.1016/j.clinthera.2014.11.010.

    PubMed 25592089

  • Kaelin WG Jr. The concept of synthetic lethality in the context of anticancer therapy. Nat Rev Cancer. 2005 Sep;5(9):689-98. doi: 10.1038/nrc1691.

    PubMed 16110319

  • Chu JS, Ge FJ, Zhang B, Wang Y, Silvestris N, Liu LJ, Zhao CH, Lin L, Brunetti AE, Fu YL, Wang J, Paradiso A, Xu JM. Expression and prognostic value of VEGFR-2, PDGFR-beta, and c-Met in advanced hepatocellular carcinoma. J Exp Clin Cancer Res. 2013 Apr 3;32(1):16. doi: 10.1186/1756-9966-32-16.

    PubMed 23552472

  • Kirstein MM, Lange A, Prenzler A, Manns MP, Kubicka S, Vogel A. Targeted therapies in metastatic colorectal cancer: a systematic review and assessment of currently available data. Oncologist. 2014 Nov;19(11):1156-68. doi: 10.1634/theoncologist.2014-0032. Epub 2014 Oct 17.

    PubMed 25326159

  • Fakhrejahani E, Toi M. Antiangiogenesis therapy for breast cancer: an update and perspectives from clinical trials. Jpn J Clin Oncol. 2014 Mar;44(3):197-207. doi: 10.1093/jjco/hyt201. Epub 2014 Jan 27.

    PubMed 24474817

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing niraparib combined with brivanib and niraparib combined with toripalimab in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site 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 11 inclusion and 36 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: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Qi Zhou, Ph.D. (13708384529, qizhou9128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 6 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 NCT04395612, which also lists 8 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 21 May 2021.

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