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NCT02664961 · REGISTRY CONDITION SEARCH

Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2019-07-23

The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Overall Response Rate on Bevacizumab Alone

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outcome · POSTED

Maximum Plasma Concentration (Cmax) of TRC105.

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outcome · POSTED

TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).

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outcome · POSTED

Frequency and Severity of Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Willingness and ability to consent for self to participate in study 2. Willingness and ability to comply with study procedures 3. Elevated serum hCG (in cases of choriocarcinoma); elevated hCG or measurable disease (in cases of PSTT or ETT) 4. Histologically proven trophoblastic neoplasia, or clinically demonstrated trophoblastic neoplasia that has progressed following treatment with at least one chemotherapy regimen that included 2 or more chemotherapy agents. 5. Age of 16 years or older 6. ECOG performance status ≤ 1 7. Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline 8. Adequate organ function Exclusion Criteria: 1. Male 2. Prior treatment with TRC105 3. . Current treatment on another therapeutic clinical trial 4. Uncontrolled chronic hypertension defined as systolic \> 150 or diastolic \> 90 despite optimal therapy 5. Significant pericardial effusion, pleural effusion, or ascites 6. Active bleeding or pathologic condition that carries a high risk of bleeding 7. Tumors located in the central chest or other location where bleeding is associated with high morbidity 8. Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy 9. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the past 6 months. Deep venous thrombosis within 6 months, unless the patient is therapeutically anti-coagulated for at least 2 weeks. In this situation, low molecular weight heparin is preferred 10. Known active viral or nonviral hepatitis 11. Pregnant or actively breastfeeding without intention to discontinue prior to initiation of study 12. Open wounds or unhealed fractures within 28 days of starting study treatment 13. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment 14. History of gastrointestinal perforation or fistula in the past 6 months, or while previously on antiangiogenic therapy, unless underlying risk has been resolved 15. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness 16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study 17. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for brain edema for at least 28 days 18. Receipt of systemic anticancer therapy, including investigational agents, within 28 days of starting study treatment. If anticancer therapy was given within 28 days of starting study treatment, patients may be included if 5 times the elimination half-life of the drug has passed 19. Patients who have received wide field radiotherapy ≤ 28 days (defined as \> 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation \< 14 days prior to starting study treatment or those patients who have not recovered adequately from side effects of such therapy 20. Major surgical procedure or significant traumatic injury within 6 weeks prior to study registration or not fully recovered from any such procedure
healthy Volunteers
false
maximum Age
99 Years
minimum Age
16 Years
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.
    intervention Names
    1. Drug: TRC105
    2. Drug: Bevacizumab
    label
    TRC105 and/or bevacizumab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. TRC105 and/or bevacizumab
    description
    Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
    name
    TRC105
    other Names
    1. Chimeric Antibody (TRC105) to CD105
    type
    DRUG
  2. arm Group Labels
    1. TRC105 and/or bevacizumab
    description
    Bevacizumab will be dosed every two weeks.
    name
    Bevacizumab
    other Names
    1. Avastin
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.
    measure
    Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab
    time Frame
    8 weeks
secondary Outcomes
  1. description
    Median Progression-Free Survival (PFS) via Serum hCG levels and response evaluation according to RECIST version 1.1 as a preliminary measure of the antitumor activity of TRC105. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. Patients must have screening (baseline) and at least one on study CT scan to be considered evaluable.
    measure
    Progression-Free Survival (PFS)
    time Frame
    8 weeks
  2. description
    Overall Response Rate on bevacizumab alone according to RECIST 1.1 in combination with serum hCG levels. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.
    measure
    Overall Response Rate on Bevacizumab Alone
    time Frame
    8 weeks
  3. description
    Mean serum TRC105 concentrations were assessed at cycle 1 and cycle 2 on day 1, 8, 15, and 22 and on day 1 of every subsequent cycle using validated methods in order to determine the Cmax of TRC105
    measure
    Maximum Plasma Concentration (Cmax) of TRC105.
    time Frame
    cycle 2 day 1 (28 days after initiation of dosing)
  4. description
    Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. Number of patients with positive APA titers on study will be reported.
    measure
    TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).
    time Frame
    8 weeks
  5. description
    Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03)
    measure
    Frequency and Severity of Adverse Events
    time Frame
    20 months
Full study description
brief Summary
The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.
detailed Description
TRC105 is a monoclonal antibody that binds to endoglin, an angiogenic target highly expressed on the tumor vessels and tumor cells in gestational trophoblastic neoplasia (GTN). Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 has been well tolerated as a single agent and when combined with bevacizumab. These antibodies may be efficacious in refractory GTN, a tumor type that is highly vascular and has been shown to densely express endoglin.
Source references
Source notices and limitations
    Discovery and provenance
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      id
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      nct id
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      occurrences
      1. context exact
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        end
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        exact text
        NCT02664961
        start
        0
      offset unit
      unicode_code_points
      query cond
      Gestational Trophoblastic Disease
      query disease state id
      ds-gestational-trophoblastic-disease
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-gestational-trophoblastic-disease-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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    Preserved source evidence · Not medical advice