A Phase 2 interventional study of Pembrolizumab Injectable Product - Chemotherapy - Bevacizumab and Chemotherapy - Bevacizumab in Ovarian Cancer Stage IV, sponsored by ARCAGY/ GINECO GROUP. Completed at 22 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by ARCAGY/ GINECO GROUP · Phase 2, Interventional, and Treatment
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Among 24 studies in Ovarian Neoplasms by ARCAGY/ GINECO GROUP — 3 open to participants now, 4 under way, 1 of them phase 3. Ovarian Neoplasms · ARCAGY/ GINECO GROUP.
Among the 24 studies in Ovarian Neoplasms by ARCAGY/ GINECO GROUP, this one is the 12th largest by enrollment of the 19 interventional ones that give a count, is one of 3 that started in 2018, is one of 10 in phase 2, and was the 15th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →3 of the 24 studies in Ovarian Neoplasms by ARCAGY/ GINECO GROUP are open now, in 7 countries. Recruiting first, the newest first:
ARCAGY/ GINECO GROUP · Sites in France, Italy, Japan and 1 more country
Ages 18+ · Women only
ARCAGY/ GINECO GROUP · Sites in France, Italy, Japan and 3 more countries
Ages 18–99 · Women only
ARCAGY/ GINECO GROUP · Sites in France
Ages 18+ · Women only
By country, each count listing its studies:
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 to 75 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.
24 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 4 · Phase 2 14 · Phase 3 3 · Phase 4 1
First in 2001; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 91 is above the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 118 across the 19 interventional studies, 204 across the 5 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
ARCAGY/ GINECO GROUP is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
2 of the studies in Ovarian Neoplasms by ARCAGY/ GINECO GROUP that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06476184Phase 3ARCAGY/ GINECO GROUPUtility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery | 2027-06 |
| NCT05183984ARCAGY/ GINECO GROUPNiraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer | 2027-02 |
Add all 2 to your calendar (.ics) → With an account.
Among the 24 studies in Ovarian Neoplasms by ARCAGY/ GINECO GROUP, from their registry updates:
This tab as a report to print or save as PDF → With an account.
There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells
This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS.
After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).
The standard procedure for initial diagnosis recommends the realization of laparoscopy first for all suspicious advanced ovarian carcinoma. This procedure should able to confirm histo-logical diagnosis and to describe the all abdominal extension of the disease.
For advanced stages, complete primary cyto-reductive surgery followed by 6 cycles of chemotherapy based remains the standard of care as first treatment in ovarian cancer. It is part of a large surgery including total hysterectomy, bilateral salpingo-oophorectomy, omentectomy, appendectomy, lymphadenectomy and removal of all peritoneal carcinomatosis.
More recently, complete resection of all macroscopic disease at primary debulking surgery has been shown to be the single most important independent prognostic factor in advanced ovarian carcinoma , and this was confirmed for interval debulking surgery (IDS) after neo adjuvant chemotherapy in the EORTC-GCG study . These results suggest that neo-adjuvant chemotherapy followed by surgical cytoreduction is an acceptable management strategy for patients with advanced ovarian cancer and is more and more frequently used in Europe in advanced ovarian cancer patients with high burden of tumor . Due to these confirmed results, the rate of patients receiving neo adjuvant chemotherapy increased over time compared to up front surgery Hence, we hypothesize that improving the response rate to neo adjuvant chemotherapy would improve the optimal debulking rate at IDS and ultimately the survival. This change of medical practices over time opened the possibility to explore new agent in combination with chemotherapy. For patients whose extent of disease is not amenable to complete or optimal upfront debulking surgery, neo adjuvant treatment with carboplatin plus paclitaxel should be considered, followed by an interval debulking surgery. A minimum of 3 cycles of carboplatin/paclitaxel must be administered before to propose interval surgery. After interval surgery, completion of the chemotherapy with 3 or 4 more chemotherapy regimen is proposed.
For patients with macroscopic residual disease or when disease remains unresectable, combination with bevacizumab to adjuvant chemotherapy then a maintenance phase of bevacizumab alone can be proposed as a standard of care Given that facts, there is a strong rationale to introduce additional neo adjuvant therapies that would strengthen the tumor shrinkage and improve the resectability rate.
Furthermore, immune surveillance plays an important role in tumor outcome of ovarian cancer patients. Indeed, clinical data in ovarian cancer patients have demonstrated that an antitumor immune response and immune evasion mechanisms are correlated, respectively, with a better and lower survival). Thus, immunotherapies are emerging as potential strategies to enhance classical EOC treatments.
More recently, they also have demonstrated significant efficacy in aggressive cancers of other histology such as metastatic Lung Cancer , metastatic Renal Cell Cancer or metastatic Bladder Cancer .
Approximately half of OC patients display a spontaneous antitumor immune response by antibodies and oligoclonal T-cells which recognize autologous tumor-associated antigens (TAAs). OC exhibits an extreme degree of heterogeneity of TAAs with an average of 60 private nonsynonymous mutations per tumor which are rarely shared among different tumors.
Though data remains scarce, high IHC PD-L1 expression (score 2 \& 3) has been detected in 68% of ovarian cancer patients (n=70) and that expression of PD-L1 had a strong prognostic value . The authors found also that the density of intraepithelial CD8+ T cells was inversely correlated to expression of PD-L1 by tumors, suggesting that the expres-sion of PD-L1 on tumor cells may inhibit invasion of tumor epithelium by CD8+ T cells.
In addition, PD-1 expression at the surface of intra-tumoral CD4+ FOXP3+ Tregs was found to show the highest levels in ovarian cancer (around 20% of the cells) compared to other tumor types, including melanoma, renal cell cancer or hepatoma . Thus targeting PD-1/PD-L1 pathway may inhibit Treg expression, one of the major component of ovarian cancer immunosuppression. Also Curiel et al showed that myeloid dendritic cells (MDCs) from ovarian cancer express PD-1 and that blockade of PD-1 enhanced MDC-mediated T-cell activation, including upregulation of IL-2 and interferon-gamma, and down regulation of IL-10, which resulted in enhanced T-cell immunity against autologous ovarian human tumors into NOD-SCID mice.
Together with the aforementioned data on immune infiltration, these data provide the rationale for a therapeutic PD-1/PD-L1 pathway blockade in ovarian cancer.
In ovarian carcinoma patients, the anti-PD1 compound nivolumab has been reported to achieve 3 objectives responses out of 13 (23%) heavily pre-treated patients. Response was prolonged over 1 year in 2 out of the 3 responders. Similarly, the anti-PD1 pembrozilumab achieved 3 confirmed responses (11.5% [(95% CI, 2.4-30.2]) in 26 patients treated in a phase IB study and 3 additional patients had a tumor reduction of at least 30%. Most common AEs were fatigue (42.3%), anemia (30.8%), and decreased appetite (30.8%). Drug-related AEs occurred in 69.2% of pts (grade ≥ 3, 1/26 pts).
The anti-PD-L1 avelumab has reported a 10.7% objective response and a 44% stabilization rate in 75 patients with ovarian cancer in relapse. In this study, con-firmed or unconfirmed responses (n=11) tend to be more frequently observed in patients with low burden of tumor, limited number of prior lines of chemotherapy and in the setting of platinum-sensitivity. Toxicity was minimal. Considering all grades, fatigue was observed in 16% of the patients, chills in 12%, nausea in 10.7%, diarrhea in 10.7%, rash in 8% and hypothyroidism in 5.3%.
Rationale for combining pembrolizumab and standard chemotherapy Kryczek et al compared the PD-1 expression level at the surface of intra-tumoral CD4+ FOXP3+ Tregs among many cancer types. Interestingly, the higher level of PD-1 expression (around 20%) was found on Tregs of ovarian cancers whereas it was much lower (\<10%) in other cancer types (Colon cancer, Hepatic cancer, Melanoma, Pancreatic carcinoma, Renal cell carcinoma). PD-L1 expression has also been detected in ovarian cancer tissue analysis by Immunohistochemistry staining and its level of expression has been correlated to a bad outcome of patients (59). Together with the aforementioned data on immune infiltration, these results provide rationale for a therapeutic PD-1/PD-L1 pathway blockade in ovarian cancer. In the published trials on such compounds, addition of pembrolizumab to chemotherapy or using alone has been shown to improve the response rates with a median time to response at 8 weeks (60,61).
Rationale for combining pembrolizumab and bevacizumab There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells.
This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS.
After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).
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.
Adequate hematological laboratory value: (ANC): ≥1,500/mm3
Adequate renal laboratory value:
Adequate hepatic laboratory value:
Adequate coagulation laboratory value:
Exclusion Criteria:
Vaccination with a within 30 days of planned start of study therapy.
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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 number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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 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.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm B (n=60): 4 neo-adjuvant cycles of standard 3 weekly Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²) Arm B: Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W) The total number of cycles of chemotherapy will be 6 cycles from the start of the neo-adjuvant chemotherapy. Three additional cycles are allowed if required (maximum 9 cycles in total). The planning of administration or not of bevacizumab will be defined before the randomization and could not be modified (stratification factor). After chemotherapy: * In the Arm A \& B, for patients receiving bevacizumab (as standard therapy) (15 mg/kg Q3W), this will be continue until a maximum of 15 months in total from the beginning of the adjuvant therapy. * In the arm B, patient will receive Pembrolizumab 200 mg until a maximum of 15 months in total from the beginning of the adjuvant therapy.
Drug: Pembrolizumab Injectable Product - Chemotherapy - Bevacizumab
Arm A (n=30): 4 neo-adjuvant cycles of standard 3 weekly carboplatin (AUC5 or 6) and paclitaxel (175mg/m²) Arm A: carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), q3 weeks +/- bevacizumab (15 mg/kg Q3W) The total number of cycles of chemotherapy will be 6 cycles from the start of the neo-adjuvant chemotherapy. Three additional cycles are allowed if required (maximum 9 cycles in total). The planning of administration or not of bevacizumab will be defined before the randomization and could not be modified (stratification factor). After chemotherapy: \- In the Arm A \& B, for patients receiving bevacizumab (as standard therapy) (15 mg/kg Q3W), this will be continue until a maximum of 15 months in total from the beginning of the adjuvant therapy.
Drug: Chemotherapy - Bevacizumab
Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
Carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Primary objective
Efficacy: Complete Resection Rate (CC0) after interval debulking surgery
Time frame: Average of 4 months after the randomization of the last patient.
Secondary objective
Efficacy : CCI score evaluated by centers and by central review
Time frame: Average of 4 months after the randomization of the last patient.
Secondary objective
Efficacy : PCI score evaluated by centers and by central review
Time frame: Average of 4 months after the randomization of the last patient.
Secondary objective
Efficacy : Rate of Pathologic Complete Response (pCR) after surgery
Time frame: Average of 4 months after the randomization of the last patient.
Secondary objective
Efficacy : Objective Response Rate (ORR)
Time frame: Average of 3 months after the first neo-adjuvant cycle.
Secondary objective
Efficacy : Best Overall Response
Time frame: From the date of randomization until the end of treatment.
Secondary objective
Efficacy : Progression-Free Survival (PFS)
Time frame: From the date of randomization to date event, assessed up to 5 years.
Secondary objective
Efficacy : Biological Progression-Free Interval (PFIBIO)
Time frame: From the date of randomization to date event, assessed up to 5 years.
Secondary objective
Efficacy : Overall survival (OS)
Time frame: From the date of randomization to death, assessed up to 5 years.
Secondary objective
Safety and Tolerability of pembrolizumab in combination with chemotherapy : Incidence of Treatment-Emergent Adverse Events
Time frame: 30 days after last treatment intake.
Secondary objective
Post-operative mortality
Time frame: 30 days after the interval debulking surgery.
Secondary objective
Post-operative morbidity
Time frame: 30 days after the interval debulking surgery.
Plan to share: No
Ran from Feb 2018 to primary completion in Sep 2020, 31 months.
Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's 31 months is below that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab
ARCAGY/ GINECO GROUP