Trial · NCT03271047
Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
NCT03271047, Phase 2, Completed, Pfizer; results first posted 2021-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation. Trials, record NCT03271047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03271047
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
- NCT number
- NCT03271047
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- MSS, RAS-mutant Colorectal Cancer
- Interventions
- binimetinib, nivolumab, ipilimumab
- First posted
- 2017-09-01
- Last updated
- 2022-01-04
- Other registries' IDs
- eudract:2017-003464-12
- Results first posted
- 2021-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Cycle 1: Day 1 up to Day 28 | DLT:Adverse event(AE)/abnormal laboratory assessed unrelated-disease,disease progression,intercurrent illness/concomitant medication/therapies resulting inability tolerate 75% dose intensity in Cycle 1.Total bilirubin(TBL)grade(G)\>=3 (\>3.0\*upper limit of normal\[ULN)\]);AST/ALT\>5-8\*ULN\>5 days,\>8\*ULN,\>3\*ULN concurrent TBL\>2\*ULN;G\>=3 serum creatinine,CK elevation,ECG QTcF prolonged,G3 troponin,electrolyte\>72 hours,G3/4 amylase/lipase.G4 ANC,platelet count\>7 days;G3/4 platelet count,other AE except lymphopenia.G\>=3 retinopathy,other disorder\>21 days;G2 uveitis/eye pain/blurred vision/decreased visual acuity;G4 other disorder.Decrease LVEF\>10% G\>=3 cardiac disorders.G3/4 hypertension.G3 fatigue\>=7 days,hypersensitivity,infusion reaction,fever\>=72 hours/hemodynamic compromise,endocrinopathy.G\>=2 interstitial lung disease/pneumonitis;G3 bronchospasm.G3/4 rash,hand foot skin reaction,photosensitivity.G3 colitis;G3/4 diarrhea,nausea/vomiting.Neurologic G3.Other hematologic/nonhematolic G\>=3 AE. |
| Primary | Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately) | ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<)10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. |
| Secondary | Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
| Secondary | Duration of Response (DOR) as Per RECIST v1.1 | From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
| Secondary | Percentage of Participants With Complete Response as Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | Complete response as per RECIST v1.1 was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs: events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy minus 1 day, whichever occurred first. TEAE graded by CTCAE grade 4.03: Grade 3: severe/medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care activities of daily living (ADL); Grade 4: life-threatening consequence, urgent intervention indicated. In this outcome measure, number of participants with 'all grades' and 'Grade 3/4' were reported. |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Hematological parameters included: Hemoglobin graded high, Hemoglobin graded low, Platelets count graded low, White Blood Cell (WBC) graded high, WBC graded low, Neutrophils graded low, Lymphocytes graded high, Lymphocytes graded low. Coagulation parameters included: International Normalized Ratio (INR) graded high, Activated Partial Thromboplastin Time (aPTT) graded high. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported. |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Hematology parameters: Basophils, Eosinophils, Hematocrit, Monocytes, Red blood cells (RBC). Coagulation parameters: Prothrombin Time. Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Laboratory parameters were graded based on laboratory normal ranges as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported. |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Abnormalities: Albumin graded low, Alkaline phosphatase (ALP) graded high, Alanine aminotransferase (ALT) graded high, Aspartate aminotransferase (AST) graded high, Bilirubin graded high, Amylase graded high, Creatinine graded high, Corrected calcium graded high, Creatine Kinase (CK) graded high, Glucose graded high, Glucose graded low, Lipase graded high, Magnesium graded high, Magnesium graded low, Potassium graded high, Potassium graded low, Sodium graded high and Sodium graded low. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported. |
| Secondary | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Chemistry laboratory parameters: Blood urea nitrogen (BUN), Total protein, Chloride, Cancer antigen 19-9 (CA 19-9), Brain natriuretic peptide (BNP), Bicarbonate, Direct bilirubin, Carcinoembryonic antigen (CEA), Lactate dehydrogenase (LDH), Uric acid, Troponin I. Thyroid panel laboratory parameters: Thyroid-stimulating hormone (TSH), Free triiodothyronine (T3), Free thyroxine (T4). Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Shift in chemistry and thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Cycle 1: Day 1 up to Day 28 | Dose-Determining Set (DDS) included all participants in Phase 1b who experienced a DLT or receive at least 75% of the planned binimetinib dose intensity during Cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately) | All participants randomized to study treatment in Phase 2. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately) | All participants who received at least 1 dose of any study treatment in Phase 1b. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Per RECIST v1.1 | From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately) | FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2. Here, Overall Number of Participants Analyzed signifies number of participants who achieved an objective response. There were no participants who had event in Phase 1b and Nivolumab and Binimetinib group of Phase 2. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Response as Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | The safety set included of all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group1,179
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Phase 1b: Nivolumab+Binimetinib | 1 | Participants | ||
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 2 | Participants | ||
| Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | Phase 2: Nivolumab+Binimetinib | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 7.4 | 95% Confidence Interval 0.9 to 24.3 | Percentage of participants | |
| Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | Phase 1b: Nivolumab+Binimetinib | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 0.0 | 95% Confidence Interval NA to NA | Percentage of participants | |
| Duration of Response (DOR) as Per RECIST v1.1 | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 11.4 | 95% Confidence Interval 7.5 to 15.2 | Months | |
| Percentage of Participants With Complete Response as Per RECIST v1.1 | Phase 1b: Nivolumab+Binimetinib | 0 | Percentage of participants | ||
| Percentage of Participants With Complete Response as Per RECIST v1.1 | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 0 | Percentage of participants | ||
| Percentage of Participants With Complete Response as Per RECIST v1.1 | Phase 2: Nivolumab+Binimetinib | 0 | Percentage of participants |
1 to 10 of 1,179Source ClinicalTrials.gov
See all 1,179 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b: Dose Finding Period | STARTED | Phase 1b: Nivolumab+Binimetinib | 10 | |
| Phase 1b: Dose Finding Period | STARTED | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 11 | |
| Phase 1b: Dose Finding Period | STARTED | Phase 2: Nivolumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | STARTED | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | COMPLETED | Phase 1b: Nivolumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | COMPLETED | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | COMPLETED | Phase 2: Nivolumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | COMPLETED | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 0 | |
| Phase 1b: Dose Finding Period | NOT COMPLETED | Phase 1b: Nivolumab+Binimetinib | 10 | |
| Phase 1b: Dose Finding Period | NOT COMPLETED | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events812
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Binimetinib | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Nivolumab+Binimetinib | 7 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 4 | 27 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Binimetinib | 1 | 10 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 0 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2: Nivolumab+Binimetinib | 0 | 27 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 0 | 27 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Binimetinib | 0 | 10 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 1 | 11 |
1 to 10 of 812Source ClinicalTrials.gov
See all 812 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Nivolumab+Binimetinib | 8 | 10 |
| Total, all-cause mortality | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 8 | 11 |
| Total, all-cause mortality | Phase 2: Nivolumab+Binimetinib | 20 | 27 |
| Total, all-cause mortality | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 21 | 27 |
| Total, other adverse events | Phase 1b: Nivolumab+Binimetinib | 10 | 10 |
| Total, other adverse events | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 11 | 11 |
| Total, other adverse events | Phase 2: Nivolumab+Binimetinib | 27 | 27 |
| Total, other adverse events | Phase 2: Nivolumab+Ipilimumab+Binimetinib | 27 | 27 |
| Total, serious adverse events | Phase 1b: Nivolumab+Binimetinib | 5 | 10 |
| Total, serious adverse events | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | 6 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38600471 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase 1b: Nivolumab+Binimetinib vs Phase 1b: Nivolumab+Ipilimumab+Binimetinib: Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03271047/results?page=2