Trial · NCT01664182

Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer

NCT01664182, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer. Trials, record NCT01664182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01664182

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trebananib With or Without Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, or Sunitinib Malate in Treating Patients With Advanced Kidney Cancer
NCT number: NCT01664182
Status: Completed
Phases: Phase 2
Enrollment: 41 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Advanced Renal Cell Carcinoma, Advanced Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
Interventions: Bevacizumab, Pazopanib Hydrochloride, Sorafenib Tosylate, Sunitinib Malate, Trebananib
First posted: 2012-08-14
Last updated: 2022-06-07
Results first posted: 2022-06-07

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Observed Response Rate	Up to 8 weeks	Defined as the total number of efficacy-evaluable patients who achieve a complete or partial response by RECIST version 1.1 criteria, assessed by MRI: Complete Response (CR), Disappearance of all target lesions: any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Best response will be listed for each patient and summarized using standard descriptive methods-point estimate and associated confidence intervals.
Primary	Tumor Response	at 8 weeks	Tumor Response Classification
Secondary	Progression Free Survival (PFS)	From start of treatment to time of progression or death, whichever occurs first, assessed up to 8 weeks	Time to reach Kaplan-Meier median survival (outcome being death or progression) (95% Confidence Interval) is reported. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered a progression.)
Secondary	Number of Participants With Grade 3, 4, 5 Toxicities Related to the Treatment Drugs	8 weeks for adverse events. Until removal from the study or to death for late adverse events, up to 12 weeks	Adverse events were graded using CTCAE version 5.0. Grades 3, 4, 5 (on a scale of 1 to 5, 5 being the worst grade - death) toxicities related ('Possibly', 'Probably', or 'Definitely') to the treatment drugs (AMG 386 alone or in combination with prior VEGF targeted agent).
Other	Changes in Circulating Angiogenic Factors	Baseline to up to 8 weeks	Analyzed as continuous variables (most likely after transformation). The gene expression results from the pretreatment tumor biopsies are expressed as ratios between that of the gene of interest and the internal reference gene beta-actin and can be analyzed as continuous variables - generally after log transformation.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Observed Response Rate	Up to 8 weeks		percentage of patients responding	NUMBER
PRIMARY	Tumor Response	at 8 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival (PFS)	From start of treatment to time of progression or death, whichever occurs first, assessed up to 8 weeks		months	MEDIAN
SECONDARY	Number of Participants With Grade 3, 4, 5 Toxicities Related to the Treatment Drugs	8 weeks for adverse events. Until removal from the study or to death for late adverse events, up to 12 weeks		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Changes in Circulating Angiogenic Factors	Baseline to up to 8 weeks	availability of samples. attrition from the study.	pg/ml	MEDIAN

Source ClinicalTrials.gov

Results by group104

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Observed Response Rate	Arm I (Trebananib Monotherapy)		0	95% Confidence Interval 0 to 20	percentage of patients responding
Observed Response Rate	Arm II (Trebananib and Anti-VEGF Therapy)		11	95% Confidence Interval 1 to 35	percentage of patients responding
Tumor Response	Arm I (Trebananib Monotherapy)	Partial Response	0		Participants
Tumor Response	Arm II (Trebananib and Anti-VEGF Therapy)	Partial Response	2		Participants
Tumor Response	Arm I (Trebananib Monotherapy)	Stable Disease	5		Participants
Tumor Response	Arm II (Trebananib and Anti-VEGF Therapy)	Stable Disease	8		Participants
Tumor Response	Arm I (Trebananib Monotherapy)	Progressive Disease	11		Participants
Tumor Response	Arm II (Trebananib and Anti-VEGF Therapy)	Progressive Disease	6		Participants
Tumor Response	Arm I (Trebananib Monotherapy)	Not Evaluable	1		Participants
Tumor Response	Arm II (Trebananib and Anti-VEGF Therapy)	Not Evaluable	2		Participants

1 to 10 of 104Source ClinicalTrials.gov

See all 104 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Trebananib Monotherapy)	19
Overall Study	STARTED	Arm II (Trebananib and Anti-VEGF Therapy)	22
Overall Study	COMPLETED	Arm I (Trebananib Monotherapy)	17
Overall Study	COMPLETED	Arm II (Trebananib and Anti-VEGF Therapy)	18
Overall Study	NOT COMPLETED	Arm I (Trebananib Monotherapy)	2
Overall Study	NOT COMPLETED	Arm II (Trebananib and Anti-VEGF Therapy)	4

Source ClinicalTrials.gov

Adverse events376

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	Anemia	Blood and lymphatic system disorders	Arm I (Trebananib Monotherapy)	5	17	5
other	Anemia	Blood and lymphatic system disorders	Arm II (Trebananib and Anti-VEGF Therapy)	6	18	6
other	Decreased RBC count	Blood and lymphatic system disorders	Arm I (Trebananib Monotherapy)	0	17	0
other	Decreased RBC count	Blood and lymphatic system disorders	Arm II (Trebananib and Anti-VEGF Therapy)	1	18	1
other	Atrial flutter	Cardiac disorders	Arm I (Trebananib Monotherapy)	0	17	0
other	Atrial flutter	Cardiac disorders	Arm II (Trebananib and Anti-VEGF Therapy)	1	18	1
other	Sinus bradycardia	Cardiac disorders	Arm I (Trebananib Monotherapy)	3	17	3
other	Sinus bradycardia	Cardiac disorders	Arm II (Trebananib and Anti-VEGF Therapy)	5	18	5
other	Sinus tachycardia	Cardiac disorders	Arm I (Trebananib Monotherapy)	2	17	2
other	Sinus tachycardia	Cardiac disorders	Arm II (Trebananib and Anti-VEGF Therapy)	3	18	3

1 to 10 of 376Source ClinicalTrials.gov

See all 376 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Trebananib Monotherapy)	0	17
Total, all-cause mortality	Arm II (Trebananib and Anti-VEGF Therapy)	2	18
Total, other adverse events	Arm I (Trebananib Monotherapy)	16	17
Total, other adverse events	Arm II (Trebananib and Anti-VEGF Therapy)	18	18
Total, serious adverse events	Arm I (Trebananib Monotherapy)	10	17
Total, serious adverse events	Arm II (Trebananib and Anti-VEGF Therapy)	18	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA033572	Cancer Center Support Grant	CARPTEN, JOHN D.	BECKMAN RESEARCH INSTITUTE/CITY OF HOPE	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I (Trebananib Monotherapy) vs Arm II (Trebananib and Anti-VEGF Therapy): deaths from any cause	Trial comparisons
Arm I (Trebananib Monotherapy) vs Arm II (Trebananib and Anti-VEGF Therapy): serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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