A Phase 1/2 interventional study of Atezolizumab and Carboplatin in Ovarian Cancer and Ovarian Neoplasms, sponsored by Duke University. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Duke University · Phase 1/2, Interventional, and Treatment
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Among 14 studies testing atezolizumab in Ovarian Neoplasms — 1 open to participants now, 4 under way, 1 of them phase 3. atezolizumab · Ovarian Neoplasms.
Among the 14 studies testing atezolizumab in Ovarian Neoplasms, this one is the 12th largest by enrollment, is one of 4 that started in 2018, is one of 2 in phase 1/2, and was the 9th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →1 of the 14 studies testing atezolizumab in Ovarian Neoplasms is open now, in 1 country. Recruiting first, the newest first:
University of Florida · Sites in United States
Ages 18–99
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
14 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 6 · Phase 2 6 · Phase 3 5
First in 2016; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 149 across the 14 interventional studies. Of the 9 that completed or were terminated, 2 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 14 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
13 studies in Ovarian Neoplasms by Duke University: none open now, 1 under way, none of them phase 3. Of 12 finished, 3 (25%) have results posted.
Among the 13 studies in Ovarian Neoplasms by Duke University, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 1/2, and was the 11th registered.
Duke University’s Ovarian Neoplasms studies by the year they started, since 1992.
1 of the studies testing atezolizumab in Ovarian Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05000294University of FloridaAtezolizumab Plus Tivozanib in Immunologically Cold Tumor Types | 2026-12 |
Add it to your calendar (.ics) → With an account.
Among the 14 studies testing atezolizumab in Ovarian Neoplasms, from their registry updates:
Among Duke University’s 13 in Ovarian Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The main purpose of this study is to validate a safe dose of atezolizumab with dose-dense paclitaxel and carboplatin when utilized with neoadjuvant chemotherapy and interval cytoreductive surgery followed by maintenance atezolizumab in women with advanced ovarian cancer.
This is a Phase IB non-randomized, single-arm, open-label study of atezolizumab in combination with primary NACT-ICS in patients with advanced-stage epithelial ovarian cancer. The target population is women with previously untreated epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) with advanced stage (FIGO III-IV) disease suitable for NACT and ICS. The following regimen will be administered every 3 weeks for 3 cycles prior to ICS, then for 3 cycles following ICS:
Each cycle is 21 days in duration and will be administered in the outpatient setting. Limited individualized flexibility in dose assignment (as noted) is permitted per physician discretion in regards to advanced-stage disease, nutritional status, ascites, non-physiologic creatinine measurements, and other comorbidities.
Three cycles of NACT with atezolizumab will be administered every 3 weeks prior to ICS (occurring between cycles 3 and 4) followed by 3 additional cycles (cycles 4-6) of chemotherapy with atezolizumab. Surgery must be performed after the third course of chemotherapy as soon as nadir counts permit, but preferably within six weeks after the completion of the third chemotherapy cycle. Fourth cycle of chemotherapy is to be administered as soon as possible, but preferably no more than six weeks after ICS.
Safety monitoring, including assessment for irAEs, will occur at each cycle and for 90 days after the last administration of atezolizumab or until start of next anti-cancer regimen, whichever occurs first. Image assessment by CT scan or MRI will be performed at baseline, prior to ICS to assess response, after completion of 6 cycles of chemotherapy with atezolizumab to assess response at end of chemotherapy treatment, and as clinically indicated during the maintenance phase and after completion of study treatment to assess PFS. Disease progression/recurrence will be defined per RECIST criteria and will not include isolated asymptomatic progression on the basis of CA125 levels. Immune function analysis will be performed on blood and tumor samples obtained at two time points: 1. confirmatory biopsy prior to start of therapy and 2. ICS.
It is estimated that 40 patients will be enrolled at an accrual rate of 3-5 patients/month and followed for a median of 3 years.
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.
Patients must meet the following criteria prior to initiation of study treatment:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Atezolizumab administered over 90 (± 15) minutes (for the first infusion, shortening to 60 (± 15) minutes and 30 ± 15) minutes for subsequent infusions as described below) followed by 2. Paclitaxel 70-80mg/m2 IV administered over approximately one hour followed by 3. Carboplatin IV administered over 15-30 minutes to achieve an initial target AUC of 5-6 mg/mL/Min (Calvert formula dosing). 4. (Optional, Physician choice) Bevacizumab IV maintenance administered starting at cycle 5 of chemotherapy over 30-90 minutes. For those who receive bevacizumab, it will be given for a total duration of 16 cycles
Drug: Atezolizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Bevacizumab
1200mg IV q3weeks
Also known as: Tecentriq
5-6mg/ML IV q3 weeks
Also known as: Paraplatin
70-80 mg/m2 IV q1 week
Also known as: Taxol
15 mg/kg IV q3 weeks
Also known as: Avastin
Safety: Incidence of Post Chemotherapy Surgical Debulking
The number of subjects able to undergo interval cytoreductive surgery will be utilized as a measure of safety regarding the initial dosing of atezolizumab.
Time frame: 9 weeks
Safety: Incidence of Treatment Emergent Adverse Events
The number of adverse events experienced while receiving study drugs will be utilized to assess safety of atezolizumab.
Time frame: 18 months
Safety: Dose Intensity
Percentage of planned doses of atezolizumab received at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject.
Time frame: Cycles 1-6,18 months total
Safety: Incidence of Dose Modifications
The number of dose modifications for atezolizumab at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject. Dose modifications are defined as doses delayed, doses discontinued, or doses held.
Time frame: Cycles 1-6,18 months total
Number of Participants With a Complete or Partial Response as Measured by RECIST (Response Evaluation Criteria in Solid Tumors)
RECIST criteria will be utilized for subjects over the course of the study to measure their response to study drugs. A Complete Response (disappearance of all tumor lesions) or Partial Response (reduction of greater than 30% in total tumor size) is considered a response.
Time frame: 18 months
Number of Participants With Pathologic Complete Remission
Cytoreduction pathologic complete remission will be measured using RECIST (Response Evaluation Criteria in Solid Tumors) and immune-related response criteria.
Time frame: 9 weeks
Progression Free Survival Rate
All patients will be evaluated for progression free survival from the date of first treatment to the date of first observation of progressive disease or death due to any cause or will be stopped at date of last follow-up for those still alive without disease progression. 18-month progression free survival rate as estimated by Kaplan-Meier method.
Time frame: 18 months
Overall Survival Rate
All patients will be evaluated for overall survival from the date of first treatment on protocol to the date of death due to any cause and will be stopped at date of last follow-up for those still alive.18-month overall survival rate as estimated by Kaplan-Meier method.
Time frame: 18 months
Translational: PD-L1 Expression
Analyzing changes in PD-L1 expression measured based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing), and progression free survival.
Time frame: 18 months
Translational: Tumor Infiltrating Lymphocytes
Analyzing changes in tumor infiltrating lymphocytes expression based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Time frame: 18 months
Translational: Immune Checkpoint Receptors
Analyzing changes in immune checkpoint receptor expression based on: flow cytometry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Time frame: 18 months
Translational: Fold Change in Cytokine Expression
Analyzing changes in cytokine expression based on: ELISA (enzyme-linked immunosorbent assay) after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Time frame: Baseline, 18 months
Translational: Gene Expression Profiles
Analyzing changes in gene expression profiles based on: RNA sequencing after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Time frame: 18 months
| Milestone | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Started | 18 |
| Completed | 3 |
| Not completed | 15 |
| Withdrew: Adverse event | 4 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Alternative therapy | 1 |
The number of subjects able to undergo interval cytoreductive surgery will be utilized as a measure of safety regarding the initial dosing of atezolizumab.
| Participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Safety: Incidence of Post Chemotherapy Surgical Debulking | 15 |
The number of adverse events experienced while receiving study drugs will be utilized to assess safety of atezolizumab.
| Participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| None (Grade 0) | 1 |
| Mild (Grade 1) | 2 |
| Moderate (Grade 2) | 9 |
| Severe (Grade 3) | 4 |
| Life Threatening (Grade 4) | 2 |
| Lethal (Grade 5) | 0 |
Percentage of planned doses of atezolizumab received at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject.
| percentage of planned doses | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Cycle 1 | 100.0 |
| Cycle 2 | 81.3 |
| Cycle 3 | 93.3 |
| Cycle 4 | 86.7 |
| Cycle 5 | 86.7 |
| Cycle 6 | 100.0 |
The number of dose modifications for atezolizumab at each cycle (21 day period) will be utilized as a measure of safety and tolerability for each subject. Dose modifications are defined as doses delayed, doses discontinued, or doses held.
| dose modifications | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Cycle 1 | 0 |
| Cycle 2 | 3 |
| Cycle 3 | 1 |
| Cycle 4 | 2 |
| Cycle 5 | 3 |
| Cycle 6 | 2 |
RECIST criteria will be utilized for subjects over the course of the study to measure their response to study drugs. A Complete Response (disappearance of all tumor lesions) or Partial Response (reduction of greater than 30% in total tumor size) is considered a response.
| Participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Number of Participants With a Complete or Partial Response as Measured by RECIST (Response Evaluation Criteria in Solid Tumors) | 12 |
Cytoreduction pathologic complete remission will be measured using RECIST (Response Evaluation Criteria in Solid Tumors) and immune-related response criteria.
| Participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Number of Participants With Pathologic Complete Remission | 0 |
All patients will be evaluated for progression free survival from the date of first treatment to the date of first observation of progressive disease or death due to any cause or will be stopped at date of last follow-up for those still alive without disease progression. 18-month progression free survival rate as estimated by Kaplan-Meier method.
| proportion of participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Progression Free Survival Rate | 0.65 (0.26 to 0.92) |
All patients will be evaluated for overall survival from the date of first treatment on protocol to the date of death due to any cause and will be stopped at date of last follow-up for those still alive.18-month overall survival rate as estimated by Kaplan-Meier method.
| proportion of participants | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Overall Survival Rate | 0.93 (0.82 to 1.00) |
Analyzing changes in PD-L1 expression measured based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing), and progression free survival.
Results for this outcome have not been posted.
Analyzing changes in tumor infiltrating lymphocytes expression based on: immunohistochemistry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Results for this outcome have not been posted.
Analyzing changes in immune checkpoint receptor expression based on: flow cytometry after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Results for this outcome have not been posted.
Analyzing changes in cytokine expression based on: ELISA (enzyme-linked immunosorbent assay) after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
| Fold change | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| CXCL10 Fold Change | 0.7 (0.2 to 3.8) |
| INFgamma Fold Change | 0.8 (0.0 to 6.0) |
| IL10 Fold Change | 0.9 (0.2 to 1.5) |
| IL12p70 Fold Change | 1.4 (0.0 to 13.5) |
| IL1b Fold Change | 0.9 (0.2 to 16.5) |
| IL2RA Fold Change | 1.1 (0.4 to 2.8) |
| IL6 Fold Change | 0.4 (0.0 to 5.6) |
| TNFalpha Fold Change | 0.8 (0.2 to 1.9) |
| TIM3 Fold Change | 1.0 (0.6 to 2.3) |
Analyzing changes in gene expression profiles based on: RNA sequencing after treatment with atezolizumab, association with BRCA mutation status, tumor mutation profile (next generation sequencing) and progression free survival.
Results for this outcome have not been posted.
Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) | 1/18 (5.6%) | 4/18 (22.2%) | 18/18 (100%) |
| Event | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Infections and infestations - Other: MRSAInfections and infestations | 1/18 |
| Neutrophil count decreasedInvestigations | 1/18 |
| HypokalemiaMetabolism and nutrition disorders | 1/18 |
| HyponatremiaMetabolism and nutrition disorders | 1/18 |
| Thromboembolic eventVascular disorders | 1/18 |
| Event | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 16/18 |
| Neutrophil count decreasedInvestigations | 16/18 |
| FatigueGeneral disorders | 15/18 |
| Platelet count decreasedInvestigations | 15/18 |
| Peripheral sensory neuropathyNervous system disorders | 14/18 |
| White blood cell decreasedInvestigations | 13/18 |
| DiarrheaGastrointestinal disorders | 12/18 |
| NauseaGastrointestinal disorders | 12/18 |
| HypoalbuminemiaMetabolism and nutrition disorders | 10/18 |
| HypocalcemiaMetabolism and nutrition disorders | 10/18 |
| Age, Continuous(years) | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Median | 67.9 ± 10.2 |
| Sex: Female, Male(Participants) | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Female | 18 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Atezolizumab, Carboplatin, Paclitaxel (+Optional Bevacizumab) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 14 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Jul 2020, 25 months.
Results were first posted in Aug 2021, 1 year after primary completion.
Of 57 non-industry phase 1/2 interventional studies under Ovarian Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 110. This study's 25 months is below that.
Counting every sponsor, half of 173 studies reached it within 65 months; a quarter within 44 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atezolizumab