A Phase 2 interventional study of Atezolizumab and Doxorubicin in Cervical Cancer, sponsored by Universitaire Ziekenhuizen KU Leuven. Active, not recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 2, Interventional, and Treatment
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Among 62 studies in Uterine Cervical Neoplasms with a site in Belgium — 9 open to participants now, 20 under way, 2 of them phase 3. Uterine Cervical Neoplasms · Belgium.
Among the 62 studies in Uterine Cervical Neoplasms with a site in Belgium, this one is the 48th largest by enrollment of the 56 interventional ones that give a count, is one of 6 that started in 2017, is one of 13 in phase 2, reaches primary completion later than 7 of the 19 other live ones, and was the 21st registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →9 of the 62 studies in Uterine Cervical Neoplasms with a site in Belgium are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in Belgium, United States, Argentina and 26 more countries
Ages 18+ · Women only
Daiichi Sankyo · Sites in Belgium, United States, Argentina and 15 more countries
Ages 18+
Universiteit Antwerpen · Sites in Belgium
Ages 25–64 · Women only
Daiichi Sankyo · Sites in Belgium, United States, Australia and 13 more countries
Ages 18+
Eli Lilly and Company · Sites in Belgium, United States, France and 6 more countries
Ages 18+
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 100 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
62 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 26 · Phase 3 10
First in 1998; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 216 across the 56 interventional studies, 134 across the 6 observational. Of the 38 that completed or were terminated, 18 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 62 have an industry lead sponsor. The 10 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 3 studies filed under Uterine Cervical Neoplasms — fewer than ten, so there is no comparison to draw.
6 of the studies in Uterine Cervical Neoplasms with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05527184AbbVieFirst in Human Study of IMGN151 in Recurrent Gynaecological Cancers | 2027-02 |
| NCT06598176Universiteit AntwerpenDeveloping a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples | 2027-02-28 |
| NCT06238479Eli Lilly and CompanyA Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT03386734Centre Hospitalier Universitaire de BesanconInternational Validation Study of Sentinel Node Biopsy in Early Cervical Cancer | 2027-05 |
| NCT05081609Ascendis Pharma Oncology Division A/SA Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies | 2027-08 |
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Among the 62 studies in Uterine Cervical Neoplasms with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A fixed dose of 1200 mg atezolizumab will be administered intravenously on Day 1 of each 21-day cycle until progressive disease
Drug: Atezolizumab
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
Drug: Atezolizumab · Drug: Doxorubicin
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
Drug: Doxorubicin
atezolizumab
Doxorubicin
Progression free survival
after 9 months in the different arms by RECIST v1.1-criteria (doxorubicin, Atezolizumab and the combination of both)
Time frame: after 9 months
Overall survival
Overall survival in the different arms (doxorubicin, Atezolizumab and the combination of both)
Time frame: after 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Sep 2025, 97 months after the start.
Of 154 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 99. This study's planned 97 months is above that.
Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atezolizumab · Doxorubicin
Universitaire Ziekenhuizen KU Leuven →