Colorectal Neoplasms, Melanoma, Neoplasms, Patients Who Have/Have Had Melanoma and Other Tumors, Prostatic Neoplasms, Renal Cell Carcinoma
Conditions
Keywords
Melanoma and other tumors
Brief summary
This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
Interventions
DRUGCP-675,206 (Tremelimumab)
15 mg/kg IV every 3 months as long as required
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* The subject must have already received tremelimumab in another protocol * Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator. * Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Serious Adverse Events to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
| Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
| Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
| Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
| Efficacy Endpoints: Survival | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first |
Countries
United Kingdom, United States
Participant flow
Recruitment details
First subject enrolled: 05 Mar 2007; Data Cut-off: 18 Jun 2020. This was a multicenter study conducted at 11 study centers in 3 countries (the United Kingdom, the United States of America and Italy).
Pre-assignment details
Total Consented/screened 38 subjects (1 of which was dead before enter any treatment), so total entered treatment 37 subjects. Subjects were assigned to treatment if they met all inclusion. 32 subjects withdrawn from this study. 6 subjects completed the study. Final Efficacy/Safety analysis 37 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Tremelimumab 15mg/kg All Patients | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Subject or physician decision, or subject relocation to another city or region. | 9 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Tremelimumab 15mg/kg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 37 |
| other Total, other adverse events | 5 / 37 |
| serious Total, serious adverse events | 4 / 37 |
Outcome results
Primary
Efficacy Endpoints: Survival
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: Treated patients with response assessed
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tremelimumab 15mg/kg | Efficacy Endpoints: Survival | Death | 10 Participants |
| Tremelimumab 15mg/kg | Efficacy Endpoints: Survival | Censored | 27 Participants |
Primary
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: Treated patients with response assessed
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tremelimumab 15mg/kg | Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | No evidence of disease | 19 Participants |
| Tremelimumab 15mg/kg | Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | Evidence of disease | 17 Participants |
| Tremelimumab 15mg/kg | Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | Indeterminate | 1 Participants |
Primary
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: 37 Participants received study treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tremelimumab 15mg/kg | Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. | Number of participants with Grade 3 or 4 tremelimumab-related adverse events to tremelimumab | 4 Participants |
| Tremelimumab 15mg/kg | Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. | Number of participants with no Grade 3 or 4 tremelimumab-related adverse events to tremelimumab | 33 Participants |
Primary
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: 37 Participants received study treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tremelimumab 15mg/kg | Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. | Number of participants with Hypersensitivity reactions to tremelimumab | 6 Participants |
| Tremelimumab 15mg/kg | Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. | Number of participants with no Hypersensitivity reactions to tremelimumab | 31 Participants |
Primary
Safety Endpoints: Serious Adverse Events to Tremelimumab.
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: 37 Participants received study treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tremelimumab 15mg/kg | Safety Endpoints: Serious Adverse Events to Tremelimumab. | Number of Participants with SAE to tremelimumab | 4 Participants |
| Tremelimumab 15mg/kg | Safety Endpoints: Serious Adverse Events to Tremelimumab. | Number of Participants with no SAE to tremelimumab | 33 Participants |
Secondary
Disease Free Survival
Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
Time frame: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Population: Treated patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tremelimumab 15mg/kg | Disease Free Survival | 3.0 Days |