Melanoma
Conditions
Brief summary
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.
Detailed description
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma. Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001.Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion. Patients will be followed up for a period of 24 months post ATL001 infusion in the study. Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.
Interventions
BIOLOGICALATL001
ATL001 infusion
Nivolumab
Sponsors
Achilles Therapeutics UK Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient must be at least 18 years old. 2. Patient must have given written informed consent. 3. Patients must have histologically confirmed diagnosis of melanoma. 4. Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures. 5. ECOG Performance Status 0-1. 6. Adequate organ function per the laboratory parameters defined in the protocol. 7. Female patients who are of childbearing potential must agree to use a highly effective method of contraception during the study for at least 12 months after the ATL001 infusion. Non-sterilised male participants who intend to be sexually active with a female partner of childbearing potential must use an acceptable method of contraception from the time of screening, throughout the duration of the study and for at least 6 months after the ATL001 infusion. 8. Anticipated life expectancy ≥ 6 months at the time of tissue procurement. 9. Measurable disease according to RECIST v1.1 criteria. Additional inclusion criteria will apply as per the study protocol.
Exclusion criteria
1. Patients with known leptomeningeal disease or untreated, symptomatic or progressing central nervous system (CNS) metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids. 2. Patients with ocular, acral or mucosal melanoma. 3. Patients with hepatitis B or C, human immunodeficiency virus infection (HIV 1/2), syphilis or HTLV I/II infection. 4. Patients requiring immunosuppressive treatments. 5. Patients requiring regular steroids at a dose higher than prednisolone 10mg/day (or equivalent). 6. Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological, or neurological disease. 7. Patients with a history of immune mediated (CNS) toxicity or ≥ Grade 2 diarrhoea/colitis caused by, , previous immunotherapy within the past 6 months. 8. Patients who are pregnant or breastfeeding. 9. Patients who have undergone major surgery in the previous 3 weeks. 10. Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate-Specific Antigen (PSA) or non-melanomatous skin cancers). 11. Patients with a history of organ transplantation. 12. Patients who have previously received any investigational cell or gene therapies. 13. Patients with contraindications for protocol specified agents. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | 60 months due to early termination | Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Assessment for Overall Response Rate | Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination) | Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy. |
| Disease Assessment for Time to Response and Duration of Response | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST. |
| Disease Assessment for Change From Baseline in Tumour Size | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma using change from baseline in tumour size at week 6, week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR). |
| Disease Assessment for Progression-Free Survival | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. |
| Overall Survival | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Evaluate overall survival (OS) by investigator |
| Disease Assessment for Disease Control Rate | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. |
Countries
Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.
ATL001: ATL001 infusion | 9 |
| Cohort B Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2.
ATL001: ATL001 infusion
Checkpoint Inhibitor: Nivolumab | 2 |
| Cohort C Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.
ATL001: ATL001 infusion | 2 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 6 | 2 | 1 |
| Overall Study | Physician Decision | 2 | 0 | 0 |
| Overall Study | study terminated by sponsor | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort A | Cohort B | Cohort C | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 2 Participants | 2 Participants | 12 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 10.49 | 59.5 years STANDARD_DEVIATION 4.95 | 36.5 years STANDARD_DEVIATION 4.95 | 49.7 years STANDARD_DEVIATION 11.09 |
| Baseline ECOG performance status Grade 0 | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Baseline ECOG performance status Grade 1 | 7 Participants | 1 Participants | 1 Participants | 9 Participants |
| Body mass index (kg/m^2) | 28.52 kg/m^2 STANDARD_DEVIATION 4.922 | 25.55 kg/m^2 STANDARD_DEVIATION 2.052 | 22.90 kg/m^2 STANDARD_DEVIATION 1.838 | 27.2 kg/m^2 STANDARD_DEVIATION 4.651 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 2 Participants | 2 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 2 Participants | 2 Participants | 13 Participants |
| Region of Enrollment Spain | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United Kingdom | 9 participants | 2 participants | 1 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 0 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 9 | 2 / 2 | 1 / 2 |
| other Total, other adverse events | 9 / 9 | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 3 / 9 | 2 / 2 | 1 / 2 |
Outcome results
Primary
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE
Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001
Time frame: 60 months due to early termination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Nivolumab related TEAEs | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs with CTCAE grade >= 3 | 2 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 | 6 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs | 3 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious IL-2 related TEAEs | 1 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs related to any component of study treatment | 1 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs related to any component of study treatment | 8 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious ATL001 related TEAEs | 1 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Lymphodepletion related TEAEs | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs with CTCAE grade >= 3 | 4 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs with CTCAE grade >= 3 | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs | 8 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | SAEs | 3 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs with CTCAE grade >= 3 | 2 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs IL-2 related TEAEs Serious TEAEs | 5 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death related to any component of study treatment | 0 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 related to any component of study treatment | 5 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs | 7 Participants |
| Cohort A | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs | 9 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious IL-2 related TEAEs | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs with CTCAE grade >= 3 | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs with CTCAE grade >= 3 | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs related to any component of study treatment | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs IL-2 related TEAEs Serious TEAEs | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs | 0 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs related to any component of study treatment | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Lymphodepletion related TEAEs | 0 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious ATL001 related TEAEs | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Nivolumab related TEAEs | 0 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 related to any component of study treatment | 2 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs with CTCAE grade >= 3 | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs with CTCAE grade >= 3 | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death | 1 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death related to any component of study treatment | 0 Participants |
| Cohort B | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | SAEs | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Nivolumab related TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 | 1 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs IL-2 related TEAEs Serious TEAEs | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs with CTCAE grade >= 3 | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs with CTCAE grade >= 3 related to any component of study treatment | 1 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs with CTCAE grade >= 3 | 1 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Lymphodepletion related TEAEs | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | SAEs | 1 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | ATL001 related TEAEs with CTCAE grade >= 3 | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs related to any component of study treatment | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs leading to death related to any component of study treatment | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious Lymphodepletion related TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs related to any component of study treatment | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | TEAEs | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious ATL001 related TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Nivolumab related TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Serious IL-2 related TEAEs | 0 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs | 2 Participants |
| Cohort C | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | IL-2 related TEAEs with CTCAE grade >= 3 | 0 Participants |
Secondary
Disease Assessment for Change From Baseline in Tumour Size
Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma using change from baseline in tumour size at week 6, week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR).
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Secondary
Disease Assessment for Disease Control Rate
Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Secondary
Disease Assessment for Overall Response Rate
Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy.
Time frame: Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Disease Assessment for Overall Response Rate | Responders | 0 Participants |
| Cohort A | Disease Assessment for Overall Response Rate | Non-Responders | 9 Participants |
| Cohort B | Disease Assessment for Overall Response Rate | Responders | 0 Participants |
| Cohort B | Disease Assessment for Overall Response Rate | Non-Responders | 2 Participants |
| Cohort C | Disease Assessment for Overall Response Rate | Responders | 0 Participants |
| Cohort C | Disease Assessment for Overall Response Rate | Non-Responders | 2 Participants |
Secondary
Disease Assessment for Progression-Free Survival
Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Secondary
Disease Assessment for Time to Response and Duration of Response
Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST.
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Secondary
Overall Survival
Evaluate overall survival (OS) by investigator
Time frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months