Cervical CancerPhase 2NCT03340376
Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
A Phase 2 study testing Atezolizumab and Doxorubicin in people with Cervical Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Atezolizumab and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Aug 2017to Sep 2025
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell or adenocarcinoma of the cervix
- At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting
- Measurable disease
- ECOG≤2
- Adequate pretreatment hematologic, renal and hepatic function test
- Patients are allowed to have had bevacizumab during their prior treatment
- Evidence of non-childbearing status for women of childbearing potential
Who cannot join
- History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years.
- Previous anthracycline-based chemotherapy
- Central nerve system metastases and leptomeningeal disease
- Active or history of autoimmune disease
- Prior allogenic bone marrow transplantation or prior solid organ transplantation
- History of idiopathic pulmonary fibrosis
Show all 10Show fewer
- Known positive test for HIV, or active hepatitis B or hepatitis C
- Known active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment
- Prior immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:
Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w
- Conditions
- Cervical Cancer
- Being tested
- Atezolizumab, Doxorubicin
- 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.
AtezolizumabDrug
atezolizumab
DoxorubicinDrug
Doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| atezolizumab monotherapy | Experimental | A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease Receives: Drug: Atezolizumab |
| atezolizumab combined with doxorubicin | Experimental | A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle. Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease Receives: Drug: Atezolizumab; Drug: Doxorubicin |
| doxorubicin monotherapy | Active comparator | Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
Measured: after 9 months
Secondary outcomes (1)
Overall survival
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Measured: after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start30 Aug 2017
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Ignace Vergote, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340376
- Sponsor's protocol ID
- BGOG-cx3
- Status last verified
- Jul 2024
- First submitted
- 5 Apr 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT03340376
- Acronym / sponsor ID
- BGOG-cx3
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:
Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| atezolizumab monotherapy | Experimental | Drug: AtezolizumabA fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease |
| atezolizumab combined with doxorubicin | Experimental | Drug: Atezolizumab, Drug: DoxorubicinA fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle. Doxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease |
| doxorubicin monotherapy | Active comparator | Drug: DoxorubicinDoxorubicin will be administered on Day 1 of each 21-day cycle at a dose of 75mg/m² for a total of 6 cycles or until progressive disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Squamous cell or adenocarcinoma of the cervix
- At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting
- Measurable disease
- ECOG≤2
- Adequate pretreatment hematologic, renal and hepatic function test
Key exclusion criteria (10 listed)
- History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years.
- Previous anthracycline-based chemotherapy
- Central nerve system metastases and leptomeningeal disease
- Active or history of autoimmune disease
- Prior allogenic bone marrow transplantation or prior solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumabatezolizumab | Drug | atezolizumab combined with doxorubicin, atezolizumab monotherapy |
| DoxorubicinDoxorubicin | Drug | atezolizumab combined with doxorubicin, doxorubicin monotherapy |
Primary outcome
Progression free survival
Time frame: after 9 months
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
1 secondary outcome
Overall survival
Time frame: after 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignace Vergote, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab and Doxorubicin in people with Cervical Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 10 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 3 Jul 2024. 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 Belgium. 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?
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?
Progression free survival (time frame: after 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.