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Cervical CancerALARICENCT03826589

Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy

A study testing Avelumab and Axitinib in people with Cervical Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

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

Official record
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Trial summary

This is a single-arm, Simon's 2-stage, proof-of-concept trial. The aim is to evaluate the efficacy and safety of avelumab with axitinib in patients with persistent or recurrent cervical cancer following platinum-based chemotherapy. 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?
Avelumab and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteHong Kong
Study dates
1 Jun 2019to 1 Jul 2024
Phase
Interventional
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

  • Patients must be at least 18 years old.
  • Patients must have histologically confirmed cervical cancer, either squamous cell, adenocarcinoma or adenosquamous, that is either persistent or recurrent after at least one prior course of platinum-based chemotherapy. The platinum used in concurrent chemo-irradiation is not counted.
  • Patients should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
  • Patients should have ECOG performance score 0 to 2.
  • Patients must have at least one target lesion by the RECIST 1.1 criteria.
  • Prior chemotherapy must have been completed at least 3 weeks before study drug administration, and all AEs have either returned to baseline or stabilized.
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  • Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. Prior focal radiotherapy must have completed at least 2 weeks before study drug administration.
  • Patients must have recovered from any major surgery that has been done at least 4 weeks before study drug administration.
  • Patients must have adequate bone marrow, renal, hepatic, thyroid and neurological function.
  • Patients should be willing to have blood tests where the blood will be used for biomarker studies.
  • Formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens of the primary tumors, should be available during screening. Alternatively, 15 unstained slides (6 minimum) will be acceptable.
  • Patients should agree for de novo biopsy if the tumors are at the cervix or vagina, or any other sites that are easy and safe to be biopsied. Tumors will be used for biomarker studies.
  • Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment

Who cannot join

  • Patients with concurrent malignancy within five years (except for basal or squamous cell skin cancer or in-situ breast cancer) are excluded.
  • Patients who have history of autoimmune diseases or other diseases requiring systemic steroid are excluded.
  • Patients with vitiligo, type I diabetes mellitus, resolved asthma or atopy, stable autoimmune thyroid disease, eczema, psoriasis not requiring systemic treatment, or not expected to recur in the absence of an external trigger are permitted to enroll.
  • Patients with the following past significant medical history in the last six months are excluded, such as pneumonitis, active or chronic viral hepatitis, cirrhosis, and inherited liver disease, myocardial infarction, unstable angina, unstable cardiac arrhythmia or clinically significant valvular heart diseases, CTCAE Grade 2 or greater peripheral vascular disease, active brain metastases or leptomeningeal metastases, uncontrolled seizures, subarachnoid hemorrhage, thromboembolic events.
  • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of the start of treatment are excluded. Inhaled, local or topical steroids, systemic corticosteroids at physiologic doses, steroid used as pre-medication are allowed.
  • Patients with severe gastrointestinal conditions such as evidence of bowel obstruction or uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease, are not eligible.
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  • Patients with uncontrolled hypertension (systolic >160mmHg or diastolic > 110mmHg) despite medication, active bleeding, bone fracture, unhealed wounds, clinically significant proteinuria (> 2g of protein over 24 hours), are excluded.
  • Patients with unhealed wounds include abdominal or pelvic fistula, gastrointestinal perforation or intra-abdominal abscess are excluded.
  • Patients having had severe infections within 4 weeks prior to the start of treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, and those who have active infection requiring systematic treatment, are excluded.
  • Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
  • Patients who have suicidal ideations or behaviors requiring psychiatric intervention within 3 months prior to the start of treatment are excluded.
  • Patients who have history of severe (CTCAE Grade 3 or above) hypersensitivity reaction to any investigational products or any component in its formulations, and any monoclonal antibody, are excluded.
  • Patients who have known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the avelumab formulation.
  • Patients who have persisting toxicities related to previous therapy (NCI CTCAE v 5.0 Grade >1) are excluded. However, alopecia, Grade 2 or less sensory neuropathy, or other toxicities of Grade 2 or below that do not constitute a safety risk according to the investigators' judgment, are allowed.
  • Patients who have received prior immunotherapy, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, are excluded.
  • Patients who have received axitinib before are excluded.
  • Patients who received other anti-angiogenics within the last 6 months are excluded.
  • Patients with prior allogeneic stem cell or solid organ transplantation are excluded.
  • Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before the start of treatment, or during the course of this trial, is not allowed.
  • Use of any live attenuated vaccines against infectious diseases (e.g. influenza, varicella, etc.) within 4 weeks (28 days) of the start of treatment and during the study therapy is not allowed.
  • Patients with major operation within 28 days or open biopsy within 7 days before enrolment are not eligible.
  • Patients planned to have major surgery during the course of the study are excluded.
  • Patients who are pregnant or breastfeeding are excluded.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy - a Proof-of-concept Study (ALARICE Study)

This is a single-arm, Simon's 2-stage, proof-of-concept trial. The aim is to evaluate the efficacy and safety of avelumab with axitinib in patients with persistent or recurrent cervical cancer following platinum-based chemotherapy. The study hypothesis is that the combination of avelumab and axitinib can significantly improve the objective response rate (ORR) with acceptable toxicity compared to traditional chemotherapy.

Read the detailed description

Cervical cancer is the fourth commonest female cancer in the world. When there is distant metastasis or recurrence, platinum-based chemotherapy is the usual treatment option. Once this first-line chemotherapy fails, the prognosis is dismal. Various second-line agents including second-line chemotherapy agents and immune checkpoint inhibitors have unsatisfactory response rate.

Conditions
Cervical Cancer
Being tested
Avelumab, Axitinib
Keywords
Cervical cancer, Avelumab, Axitinib
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.

  • AvelumabDrug

    Also called Bavencio

    an anti-programmed cell death ligand 1

  • AxitinibDrug

    Also called Inlyta

    a tyrosine kinase inhibitor that also inhibits VEGF receptor 1-3, c-KIT and PDGFR

Study groups in NCT03826589
Study groupRoleWhat they receive
Avelumab and AxitinibExperimental* Avelumab: IV treatment; administered at 10 mg/kg IV every two weeks in a 4-weekly cycle up to 12 cycles or until disease progression or intolerable side effects (whichever occurs first) * Axitinib: Oral treatment; administered at 5 mg PO BID in a 4-weekly cycle up to 12 cycles or until disease progression or intolerable side effects (whichever occurs first)
Receives: Drug: Avelumab; Drug: Axitinib

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients who have a CR or PR to the study drugs.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    The time from first dose of trial medication to first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  2. Overall survival

    Overall survival is defined as the time from first dose of trial medication to date of death due to any cause.

    Measured: Up to 2 years

  3. Objective tumor response rate

    Objective tumor response rate according to the immune-related ResponseCriteria Derived from RECIST 1.1 (irRECIST)

    Measured: Up to 2 years

  4. Disease control rate at 12 weeks

    Disease control rate at 12 weeks including complete response (CR), partial response (PR), stable disease (SD)

    Measured: Up to 2 years

  5. Duration of response

    Duration of response and duration of clinical benefit including CR, PR and SD

    Measured: Up to 2 years

  6. Rates of abnormal laboratory values and/or adverse events that are related to the treatment drugs

    Treatment-related adverse events classified by CTCAE version 5.0 and laboratory safety assessments

    Measured: Up to 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 posted1 Feb 2019
  2. Study start1 Jun 2019
  3. Primary completion1 Mar 2024
  4. Study completion1 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826589
Sponsor's protocol ID
WI224183 / UW 18-417
Acronym
ALARICE
Status last verified
Jun 2025
First submitted
30 Jan 2019
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Avelumab and Axitinib in people with Cervical Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

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 13 inclusion and 23 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 11 Jun 2025. 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 Hong Kong. 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.

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?

Objective response rate (ORR) (time frame: Up to 2 years). 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 NCT03826589.

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 11 Jun 2025.

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