Trial Outcomes & Findings for Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma (NCT NCT00145158)

Last Updated: 2022-10-10

Results Overview

Peripheral blood lymphocytes (PBL) were collected prior to the first dose of vaccine and after the completion of the six vaccinations in Week 13. Specific CTL directed against the 8 vaccine antigens ( NA17.A2, MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 and Tyrosinase.A2) was assessed by using re-stimulation in vitro, followed by staining with the corresponding tetramer (MLPC/tetramer). A patient was considered to have a positive CTL response when the post-vaccine CTL response against at least one of the vaccine antigens was ten times higher than the corresponding pre-treatment value.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Week 13

Results posted on

2022-10-10

Participant Flow

The study was to recruit 28 patients; 14 in each group. The first subject was treated on January 18, 2005. The study was prematurely closed in November 2007 as 6 of the 8 peptides had expired.

Participant milestones

Participant milestones
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Overall Study STARTED	16	7
Overall Study COMPLETED	14	4
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Overall Study premature withdrawal	2	3

Baseline Characteristics

Immunization With 8 Peptides Mixed With CpG 7909 or Montanide ISA51 in Patients With Metastatic Cutaneous Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=16 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=7 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.	Total n=23 Participants Total of all reporting groups
Age, Customized ≥ to 18 years	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Belgium	16 participants n=5 Participants	7 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 13

Population: Patients who received at least six vaccinations and had samples taken at Week 13.

Outcome measures

Outcome measures
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=14 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=3 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. Patients with CTL Response	6 Participants	1 Participants
Number of Patients With Cytotoxic T-lymphocyte (CTL) Response to Individual Peptides After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51. Patients with no CTL Response	8 Participants	2 Participants

SECONDARY outcome

Timeframe: up to Week 13

Population: All patients who received at least one immunization.

Toxicity was evaluated according to the National Cancer Institute (CTC Scale Version 3.0, published December 12, 2003). Dose limiting toxicity (DLT) is defined as: * Any Grade 3 hematological or non-hematological toxicity other than skin or flu-like symptoms * Any Grade 4 toxicity To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.

Outcome measures

Outcome measures
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=16 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=7 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Number of Patients With Dose Limiting Toxicities (DLT).	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 13

Population: Patients who received at least six immunizations and had tumor response measured at Week 13.

Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor measurements were taken at screening and at the end of Cycle 1 in Week 13. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.

Outcome measures

Outcome measures
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=14 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=4 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. Complete Response (CR)	0 Participants	0 Participants
Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. Partial Response (PR)	0 Participants	0 Participants
Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. Stable Disease (SD)	4 Participants	0 Participants
Number of Patients With Tumor Responses After Immunization With a Combination of 8 Peptides and CpG 7909 or Montanide ISA51 as Measured by RECIST. Progressive Disease (PD)	10 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 13

Population: Patients who had pretreatment tumor samples analyzed for gene expression, received at least six immunizations and had CTL responses at Week 13.

Gene expression was determined by RT-PCR on a pre-treatment tumor sample. The correlation of the induction of a CTL response against a defined antigen to the prior expression of the gene coding for this antigen by the tumor removed before vaccination was assessed.

Outcome measures

Outcome measures
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=6 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=1 Participants Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Number of Patients With Cytotoxic T-lymphocyte (CTL) Responses and Tumor Expression of the Corresponding Genes.	3 Participants	1 Participants

Adverse Events

Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: 8 HLA-A2-restricted Peptides and CpG 7909 n=16 participants at risk Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with CpG 7909, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously).	Cohort 2: 8 HLA-A2-Restricted Peptides and Montanide ISA51 n=7 participants at risk Patients with metastatic cutaneous melanoma, with at least one detectable metastasis (grades AJCC 2002 III N2b to N3, grades IV M1a, M1b, and M1c without elevation of the LDH rate and without central nervous system toxicity) received six sequential immunizations with 8 peptides presented by HLA-A2 and mixed with Montanide ISA51, at 2-week intervals. The 8 peptides were to be injected at 8 distinct injection sites. These peptides are the following: MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2 (ALKD), and NA17.A2 (20% intradermally and 80% subcutaneously); NY-ESO-1.A2 and Tyrosinase.A2 (100% subcutaneously). The Tyrosinase.A2 was administered without Montanide ISA51.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	18.8% 3/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Skin and subcutaneous tissue disorders Angioedema	6.2% 1/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Vascular disorders Deep vein thrombosis	6.2% 1/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor haemorrhage	6.2% 1/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Cardiac disorders Bradycardia	6.2% 1/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	14.3% 1/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 1/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	0.00% 0/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	14.3% 1/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/16 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.	14.3% 1/7 • up to 45 months All adverse events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent, were to be documented. Toxicities were graded according to the scale of the National Cancer Institute, CTC Scale Version 3.0, published on December 12, 2003.

Other adverse events

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place