A Phase 2 interventional study of CDX-011 and Capecitabine in Metastatic gpNMB Over-expressing Triple Negative Breast Cancer, sponsored by Celldex Therapeutics. Completed at 140 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Celldex Therapeutics · Phase 2, Interventional, and Treatment
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the efficacy and safety of CDX-011 in patients with advanced TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine.
Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 327 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Celldex Therapeutics is the lead sponsor of 45 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
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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.
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
Diagnosed with metastatic (i.e., cancer that has spread) TNBC
Exclusion:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Drug: Capecitabine
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
Drug: CDX-011
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
Duration of Response
Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
Overall Survival
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
Time frame: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
Adverse Events (AE)
The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
Time frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
Pharmacokinetics (PK)
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.
Time frame: Following 1 dose of CDX-011.
| Milestone | Capecitabine | CDX-011 |
|---|---|---|
| Started | 109 | 218 |
| Completed | 6 | 15 |
| Not completed | 103 | 203 |
| Withdrew: Disease progression | 70 | 159 |
| Withdrew: Adverse event | 10 | 32 |
| Withdrew: Physician decision | 0 | 4 |
| Withdrew: Withdrawal by subject | 6 | 3 |
| Withdrew: Did not receive treatment | 17 | 5 |
| Milestone | Capecitabine | CDX-011 |
|---|---|---|
| Started | 92 | 213 |
| Completed | 76 | 199 |
| Not completed | 16 | 14 |
| Withdrew: Withdrawal by subject | 15 | 6 |
| Withdrew: Lost to follow-up | 0 | 6 |
| Withdrew: Various | 1 | 2 |
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
| months | Capecitabine | CDX-011 |
|---|---|---|
| Progression Free Survival (PFS) | 2.8 (1.6 to 3.2) | 2.9 (2.8 to 3.5) |
ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
| percentage of participants | Capecitabine | CDX-011 |
|---|---|---|
| Objective Response Rate (ORR) | 21 (14 to 30) | 26 (20 to 33) |
Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
| months | Capecitabine | CDX-011 |
|---|---|---|
| Duration of Response | 4.2 (2.7 to 5.6) | 2.8 (2.3 to 5.5) |
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
| months | Capecitabine | CDX-011 |
|---|---|---|
| Overall Survival | 8.7 (6.9 to 10.8) | 8.9 (7.9 to 10.5) |
The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
| Participants | Capecitabine | CDX-011 |
|---|---|---|
| Patients with at least 1 AE | 92 | 211 |
| Patients with at least 1 treatment related AE | 84 | 204 |
| Patients with Grade 1 treatment related AE | 7 | 7 |
| Patients with Grade 2 treatment related AE | 33 | 54 |
| Patients with Grade 3 treatment related AE | 44 | 114 |
| Patients with Grade 4 treatment related AE | 8 | 32 |
| Patients with Grade 5 treatment related AE | 0 | 4 |
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.
| ug/ml | CDX-011 |
|---|---|
| Cycle 1 post infusion ADC levels | 58.6 (38.8 to 98.3) |
| Cycle 1 post infusion TA levels | 49.4 (21.4 to 127.4) |
| Cycle 1 post infusion MMAE levels | 0.0015 (0.0004 to 0.005) |
Collected over Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine | 65/92 (70.7%) | 19/92 (20.7%) | 91/92 (98.9%) |
| CDX-011 | 134/213 (62.9%) | 71/213 (33.3%) | 211/213 (99.1%) |
| Event | Capecitabine | CDX-011 |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/92 | 6/213 |
| VomitingGastrointestinal disorders | 4/92 | 7/213 |
| NauseaGastrointestinal disorders | 3/92 | 8/213 |
| PyrexiaGeneral disorders | 1/92 | 7/213 |
| FatigueGeneral disorders | 3/92 | 2/213 |
| Abdominal painGastrointestinal disorders | 2/92 | 6/213 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/92 | 6/213 |
| PneumoniaInfections and infestations | 0/92 | 5/213 |
| SepsisInfections and infestations | 1/92 | 5/213 |
| EnterocolitisGastrointestinal disorders | 2/92 | 0/213 |
| Event | Capecitabine | CDX-011 |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 44/92 | 55/213 |
| FatigueGeneral disorders | 37/92 | 101/213 |
| Palmar-plantar erythrodysaethesia syndromeSkin and subcutaneous tissue disorders | 40/92 | 10/213 |
| NauseaGastrointestinal disorders | 39/92 | 91/213 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/92 | 88/213 |
| PruritisSkin and subcutaneous tissue disorders | 4/92 | 69/213 |
| Decreased appetiteMetabolism and nutrition disorders | 17/92 | 63/213 |
| ConstipationGastrointestinal disorders | 13/92 | 61/213 |
| StomatitisGastrointestinal disorders | 24/92 | 37/213 |
| NeutropeniaBlood and lymphatic system disorders | 5/92 | 49/213 |
| Age, Continuous(years) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Median | 55 (31 to 85) | 55 (28 to 85) | 55 (28 to 85) |
| Sex: Female, Male(Participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Female | 109 | 218 | 327 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 11 | 16 |
| Not Hispanic or Latino | 99 | 191 | 290 |
| Unknown or Not Reported | 5 | 16 | 21 |
| Race (NIH/OMB)(Participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 9 | 20 | 29 |
| White | 91 | 176 | 267 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 16 | 23 |
| Region of Enrollment(participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Canada | 7 | 5 | 12 |
| Belgium | 2 | 6 | 8 |
| United States | 72 | 143 | 215 |
| Italy | 6 | 7 | 13 |
| United Kingdom | 5 | 6 | 11 |
| Australia | 3 | 15 | 18 |
| France | 4 | 14 | 18 |
| Germany | 5 | 9 | 14 |
| Spain | 5 | 13 | 18 |
| Number of prior relapses in advanced stage(participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| 0 | 21 | 45 | 66 |
| 1 | 58 | 122 | 180 |
| 2 | 24 | 42 | 66 |
| 3 | 6 | 9 | 15 |
| Number of cytotoxic regimens in advanced stage(cytotoxic regimen) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Median | 1 (0 to 4) | 1 (0 to 3) | 1 (0 to 4) |
| Prior Taxane Use(Participants) | Capecitabine | CDX-011 | Total |
|---|---|---|---|
| Count of participants | 108 | 218 | 326 |
2 further baseline measures are reported on the registry.
Showing the first 100 of 140 sites across 9 countries.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glembatumumab vedotin