Endometrial CancerPhase 2NCT02730416
Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer
A Phase 2 study of Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 37 sites in 7 countries.
Trial summary
This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 12 Dec 2016to 25 Nov 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmed endometrial cancer. (FIGO 2009)
- Stage 3C 2
- Stage 4 A \& B
- Relapsed after adjuvant therapy for stage 1-3 disease
- Patients may have undergone primary surgery.
- Patients may have received adjuvant chemotherapy for stage 1 - 3.
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- Patients may have received vaginal brachytherapy
- Patients may have received external beam radiotherapy. Patients who are to be enrolled for stage 3C2 diseases are allowed to receive external beam radiotherapy prior to trial entry.
- Patients may have received hormonal treatment
- Patients must have measurable disease or non-measurable disease on CT scan according to RECIST 1.1 outside irradiated field. For stage 3C2 disease patients without measureable or non-measureable disease are accepted.
- Patients must give informed consent
- ECOG performance status of 0 -1
- Patients must have an adequate organ function
- Life expectancy of at least 12 weeks
- Patients must be fit to receive combination chemotherapy
- Patient's age >18 years
- Patients with preserved reproductive capacity must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment
Who cannot join
- Sarcomas, small cell carcinoma with neuroendocrine differentiation or non-epithelial cancers.
- Concurrent cancer therapy
- Previous Chemotherapy for stage 4 disease or for relapsed disease.
- Previous treatment with anti-angiogenic/anti VEGF therapy including nintedanib.
- Concurrent treatment with an investigational agent or participation in another clinical trial.
- Treatment within 28 days prior to randomisation with any investigational drug, radiotherapy, immunotherapy, chemotherapy, hormonal therapy or biological therapy. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease.
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- Major injuries or surgery within the past 21 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
- Relapse within six months after adjuvant chemotherapy (treatment-free interval < 182 days).
- Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least three years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
- Evidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the Investigator's judgement, make the patient inappropriate for this study.
- Known contraindications to VEGF directed therapy Target Disease Exceptions
- Known uncontrolled hypersensitivity to the investigational drugs.
- History of major thromboembolic event defined as:
- Uncontrolled pulmonary embolism (PE)
- Deep venous thrombosis (DVT)
- Other related conditions, though patients with stable therapeutic anticoagulation for more than three months prior randomization are eligible for this study.
- History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 3 months.
- History of clinically significant haemorrhage in the past 3 months.
- Radiotherapy to the target lesion within the past 3 months prior to baseline imaging
- Persistant grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, except alopecia. Patients with ongoing ≥ Grade 2 neuropathy are to be excluded.
- Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation).
- Leptomeningeal disease
- Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion) See Appendix 12.
- Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 3 months afterwards.
- Radiographic evidence of cavitating or necrotic tumours with invasion of adjacent major blood vessels.
- Active or chronic hepatitis C and/or B infection
- Known hypersensitivity to the trial drugs, or to their excipients.
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Unable or unwilling to swallow tablets/capsules
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
Germany11 sites
Charité Campus Virchow Clinic
Berlin, 13353
Klinik Chemnitz gGmbH
Chemnitz, 09116
University Hospital Carl Gustav Carus Dresden
Dresden, 01307
Universitätsklinikum Essen
Essen, 45122
Kliniken Essen Mitte
Essen, 45135
Center of Gynecology and Obstetrics
Frankfurt, 60596
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
St. Vincentius-Kliniken gAG Frauenklinik mit Hebammenlehranstalt
Karlsruhe, 76137
Universitätsfrauenklinik Mainz
Mainz, 55131
Universitätsfrauenklinik am Klinikum Südstadt Rostock
Rostock, 18059
Universitätsfrauenklinik Ulm
Ulm, 89075
France10 sites
Institute Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Oscar Lambret
Lille, 59020
Léon Bérard Center
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13009
ICM (Cancer Institute of Montpellier)
Montpellier
Centre Antoine Lacassagne
Nice, 06189
Hospital Group Diaconesses Croix Saint-Simon
Paris, 75012
Private Hospital Of Côtes D'armor
Plérin, 22 190
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
Belgium5 sites
Onze Lieve Vrouwziekenhuis
Aalst, 9300
Cliniques universitaires Saint-Luc
Brussels, 1200
Antwerp University Hospital
Edegem, 2650
Ghent University Hospital
Ghent, 9000
University Hospitals Leuven
Leuven, 3000
Denmark4 sites
Aalborg Universitetshospital
Aalborg, Jylland, 9000
Rigshospitalet
Copenhagen, Region Sjælland, 2100
Odense Universitetshospital
Odense, Fyn, 5000
Vejle Sygehus
Vejle, Jylland, 7100
Sweden4 sites
Linköping University Hospital
Linköping, 58185
Skåne University Hospital
Lund, 221 85
Karolinska University Hospital
Stockholm, 171 76
Uppsala University Hospital
Uppsala, 751 85
Finland2 sites
Kuopio University Hospital
Kuopio, 70029
Tampere University Hospital
Tampere, 33520
About this study
Official title: ENGOT-EN1/FANDANGO: A Randomized Phase II Trial of First-line Combination Chemotherapy With Nintedanib / Placebo for Patients With Advanced or Recurrent Endometrial Cancer
This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.
Read the detailed description
This multicenter, prospective, double-blind, placebo-controlled, randomised phase 2 study is evaluating combination chemotherapy with nintedanib in patients with primary advanced stage (3C2 \& 4), or with first relapse of endometrial cancer.
Patients are stratified according to:
- Stage of disease (stage 3C2 vs. stage 4 vs. recurrent disease)
- Prior adjuvant chemotherapy (yes/no)
- Disease status (Measurable disease vs. non-measurable /RECIST 1.1)
Patients are randomized to one of the two treatment arms 1:1 randomization:
- Arm A: Paclitaxel and Carboplatin (6 courses) and Nintedanib (until PD). (Experimental arm)
- Arm B: Paclitaxel and Carboplatin (6 courses) and Placebo (until PD) (Control Arm)
Primary endpoint is PFS. 148 patients to be enrolled.
- Conditions
- Endometrial Cancer
- Being tested
- Nintedanib or Placebo; Carboplatin, Paclitaxel
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib or Placebo; Carboplatin, PaclitaxelDrug
Arm A: Nintedanib: 200mg orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD Arm B: Placebo: orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD In both arms: 6 courses of standard carboplatin and paclitaxel: Carboplatin AUC 5 iv every 21 days; Paclitaxel 175mg/m2 iv every 21 days. Both drugs are continued for maximum six courses or until unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| A: Nintedanib | Experimental | Nintedanib 200mg twice daily days 2-21 every 21 days for 6 courses during simultaneous treatment with carboplatin-paclitaxel; afterwards in maintenance 200mg twice daily days 1-21 every 21 days. Treatment continues until progression or unacceptable toxicity. Receives: Drug: Nintedanib or Placebo; Carboplatin, Paclitaxel |
| B: Placebo | Placebo comparator | Placebo twice daily days 2-21 every 21 days for 6 courses during simultaneous treatment with carboplatib-paclitaxel; afterwards in maintenance 200mg twice daily days 1-21 every 21 days. Treatment continues until progression or unacceptable toxicity. Receives: Drug: Nintedanib or Placebo; Carboplatin, Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS: Difference in months of Median Progression-Free Survival in experimental arm versus comparator arm
Superiority of Nintedanib arm vs. placebo arm by median PFS increase of 4 months (from 10 months to 14 months) HR: 1.4; power80%; one-sided alpha: 15%. Inclusion period 18 months. Median PFS matures after 14 months of end inclusion
Measured: 36 months
Secondary outcomes (11)
PFS in the sub-populations as described under stratification factors
To be measured (in months) and reported
Measured: 32 months
PFS after consecutive treatment (PFS2). To be measured (in months) and reported
PFS2 is defined along the same timelines as PFS but accounts for the time from randomization to progression or death by any cause on any subsequent line of anticancer therapy.
Measured: 48 months
Disease Specific Survival (DSS)
To be measured (in months) and reported
Measured: 48 months
TSST (Time to Second Subsequent Therapy)
To be measured (in months) and reported
Measured: 48 months
TFST (Time to First Subsequent Therapy)
To be measured (in months) and reported
Measured: 48 months
Overall Survival (OS)
To be measured (in months) and reported
Measured: 48 months
Response Rate (RR).
To be measured (CRs \& PRs in %) and reported
Measured: 32 months
Disease Control Rate (DCR)
Disease Control Rate (DCR = Complete Response, Partial Response or Stable Disease for at least 12 weeks). To be measured (CRs, PRs \& SDs in %) and reported
Measured: 32 months
Patient Related Outcomes (PROs)
Patient questionnaire results to be presented as as narrative (1-10 scale)
Measured: 48 months
Number of patients with Grade 3 through Grade 5 Adverse Events that are related to study drug.
NCI CTCAE Version 4.0
Measured: 36 months
Compliance in the two treatment arms
Percentage of missed dosages during the treatment
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start12 Dec 2016
- Primary completion20 Oct 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Collaborators
- North Eastern German Society of Gynaecological Oncology, Belgian Gynaecological Oncology Group, ARCAGY/ GINECO GROUP
- Responsible party
- Sponsor
- Investigators
- Mansoor R Mirza, MD, Study chair, NSGO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730416
- Sponsor's protocol ID
- ENGOT-EN1/FANDANGO
- Status last verified
- Jul 2025
- First submitted
- 14 Jan 2016
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request.
Publications
Lindemann K, Berton D, Sehouli J, Christensen RD, Altintas S, Knudsen AO, Heudel PE, Ataseven B, Vergote I, Lindahl G, Lebreton C, Schochter F, Auranen A, Follana P, Madsen K, Selle F, Petersson KS, Joly F, Braicu EI, Mirza MR. NSGO-FANDANGO/ENGOT-EN1: A randomized phase II study of first-line combination chemotherapy with nintedanib/placebo in advanced/recurrent endometrial cancer. Gynecol Oncol. 2025 Aug;199:79-87. doi: 10.1016/j.ygyno.2025.06.008. Epub 2025 Jun 30.
PubMed 40592025
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGOT-EN1/FANDANGO: A Randomized Phase II Trial of First-line Combination Chemotherapy With Nintedanib / Placebo for Patients With Advanced or Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02730416
- Acronym / sponsor ID
- ENGOT-EN1/FANDANGO
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Collaborators
- North Eastern German Society of Gynaecological Oncology, Belgian Gynaecological Oncology Group, ARCAGY/ GINECO GROUP
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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 study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.
Detailed description
This multicenter, prospective, double-blind, placebo-controlled, randomised phase 2 study is evaluating combination chemotherapy with nintedanib in patients with primary advanced stage (3C2 \& 4), or with first relapse of endometrial cancer.
Patients are stratified according to:
- Stage of disease (stage 3C2 vs. stage 4 vs. recurrent disease)
- Prior adjuvant chemotherapy (yes/no)
- Disease status (Measurable disease vs. non-measurable /RECIST 1.1)
Patients are randomized to one of the two treatment arms 1:1 randomization:
- Arm A: Paclitaxel and Carboplatin (6 courses) and Nintedanib (until PD). (Experimental arm)
- Arm B: Paclitaxel and Carboplatin (6 courses) and Placebo (until PD) (Control Arm)
Primary endpoint is PFS. 148 patients to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Nintedanib | Experimental | Drug: Nintedanib or Placebo; Carboplatin, PaclitaxelNintedanib 200mg twice daily days 2-21 every 21 days for 6 courses during simultaneous treatment with carboplatin-paclitaxel; afterwards in maintenance 200mg twice daily days 1-21 every 21 days. Treatment continues until progression or unacceptable toxicity. |
| B: Placebo | Placebo comparator | Drug: Nintedanib or Placebo; Carboplatin, PaclitaxelPlacebo twice daily days 2-21 every 21 days for 6 courses during simultaneous treatment with carboplatib-paclitaxel; afterwards in maintenance 200mg twice daily days 1-21 every 21 days. Treatment continues until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histological confirmed endometrial cancer. (FIGO 2009)
- Patients may have undergone primary surgery.
- Patients may have received adjuvant chemotherapy for stage 1 - 3.
- Patients may have received vaginal brachytherapy
- Patients may have received external beam radiotherapy. Patients who are to be enrolled for stage 3C2 diseases are allowed to receive external beam radiotherapy prior to trial entry.
Key exclusion criteria (30 listed)
- Sarcomas, small cell carcinoma with neuroendocrine differentiation or non-epithelial cancers.
- Concurrent cancer therapy
- Previous Chemotherapy for stage 4 disease or for relapsed disease.
- Previous treatment with anti-angiogenic/anti VEGF therapy including nintedanib.
- Concurrent treatment with an investigational agent or participation in another clinical trial.
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 |
|---|---|---|
| Nintedanib or Placebo; Carboplatin, PaclitaxelArm A: Nintedanib: 200mg orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD Arm B: Placebo: orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD In both arms: 6 courses of standard carboplatin and paclitaxel: Carboplatin AUC 5 iv every 21 days; Paclitaxel 175mg/m2 iv every 21 days. Both drugs are continued for maximum six courses or until unacceptable toxicity | Drug | A: Nintedanib, B: Placebo |
Primary outcome
PFS: Difference in months of Median Progression-Free Survival in experimental arm versus comparator arm
Time frame: 36 months
Superiority of Nintedanib arm vs. placebo arm by median PFS increase of 4 months (from 10 months to 14 months) HR: 1.4; power80%; one-sided alpha: 15%. Inclusion period 18 months. Median PFS matures after 14 months of end inclusion
11 secondary outcomes
PFS in the sub-populations as described under stratification factors
Time frame: 32 months
PFS after consecutive treatment (PFS2). To be measured (in months) and reported
Time frame: 48 months
Disease Specific Survival (DSS)
Time frame: 48 months
TSST (Time to Second Subsequent Therapy)
Time frame: 48 months
TFST (Time to First Subsequent Therapy)
Time frame: 48 months
Overall Survival (OS)
Time frame: 48 months
Response Rate (RR).
Time frame: 32 months
Disease Control Rate (DCR)
Time frame: 32 months
Patient Related Outcomes (PROs)
Time frame: 48 months
Number of patients with Grade 3 through Grade 5 Adverse Events that are related to study drug.
Time frame: 36 months
Compliance in the two treatment arms
Time frame: 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 40592025Lindemann K, Berton D, Sehouli J, Christensen RD, Altintas S, Knudsen AO, Heudel PE, Ataseven B, Vergote I, Lindahl G, Lebreton C, Schochter F, Auranen A, Follana P, Madsen K, Selle F, Petersson KS, Joly F, Braicu EI, Mirza MR. NSGO-FANDANGO/ENGOT-EN1: A randomized phase II study of first-line combination chemotherapy with nintedanib/placebo in advanced/recurrent endometrial cancer. Gynecol Oncol. 2025 Aug;199:79-87. doi: 10.1016/j.ygyno.2025.06.008. Epub 2025 Jun 30.
- Individual participant dataSharing planned: Yes. Upon request.
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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.
Mansoor R Mirza, MD study chair
NSGO
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Endometrial Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 37 sites in 7 countries.
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 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, France, Belgium, Denmark, Sweden and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS: Difference in months of Median Progression-Free Survival in experimental arm versus comparator arm (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730416, which also lists 1 linked publication.
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 29 Jul 2025.