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ME17

A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination with Immune Checkpoint Blockade in Patients with Advanced Melanoma


Complexity Level: 2

Eligibility: MAIN INCLUSION CRITERA: Adults over 18 years of age with histological diagnosis of cutaneous melanoma or melanoma of unknown primary; Confirmed stage IV or advanced unresectable melanoma; Must have measurable disease; ECOG 0-2; No prior ICB treatment for advanced unresectable or metastatic disease; Able to ingest capsules. MAIN EXCLUSION CRITERIA: Antibiotic treatment in last 14 days; Corticosteroid use of > 10mg per day; Any absolute contraindications to FMT ; Active infections requiring antibiotic treatment.

Objectives: PRIMARY: Progression Free Survival (PFS) (per RECIST 1.1) in standard of care ICB arm vs. standard of care ICB + FMT arm. SECONDARY: Compere treatment arms with respect to Overall Survival (OS), ORR, and safety and tolerability. EXPLORATORY: To evaluate acquired donor-host similarity and its association with PFS in the FMT treatment arm; to evaluate engraftment and its association with progression-free survival in the FMT treatment arm; to evaluate the impact of FMT on the gut microbiota, gut metabolome and systemic immune response.

NCT Registration ID (from clinicaltrials.gov): NCT06623461
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Arielle Elkrief, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000, (Canada) Dr. John Lenehan, London Regional Cancer Program, (519) 685-8640, (Canada) Dr. Bertrand Routy, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000, (Canada) Dr. Rahima Jamal, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444


Planned
ME13

A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)

"PD-1 inhibitors" are new immunotherapeutic agents effective in prolonging survival in metastatic melanoma. Currently, patients are being offered continuous treatment with approved and publically-funded PD-1 inhibitors for 24 months. However, some data suggest that patients respond early and may respond again at treatment re-induction. Given that PD-1 inhibitors are expensive and may lead to serious immune-related adverse reactions, the optimal treatment duration for these agents is one of the key questions for clinicians, governments and patients. This trial hypothesizes that intermittent PD-1 inhibitor treatment, following maximum benefit on initial treatment, is no worse for survival compared to continuous treatment for 24 months. If confirmed, this strategy will be practice-changing and it is anticipated that it will result in less toxicities, better quality of life and decreased costs.


Complexity Level: 2

Eligibility: Patients with unresectable / metastatic (stage III or stage IV) melanoma, who are eligible to receive Health Canada approved, publically-funded PD-1 inhibitors.

Objectives: PRIMARY: To determine whether the Overall Survival (OS) of patients randomized to intermittent PD-1 inhibitor therapy is non-inferior to that of patients randomized to continuous PD-1 inhibitor therapy, in unresectable / metastatic (stage III or stage IV) melanoma. SECONDARY OBJECTIVES: (1) Progression-Free Survival, (2) Response rate and duration of response, (3) Adverse Events profile, (4) Quality of Life and (5) Economic Evaluation

NCT Registration ID (from clinicaltrials.gov): NCT02821013
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: July 04, 2016

Chair: (Canada) Dr. Ian Watson, Canada Research Chair II in Functional Genomics of M, (514) 398-3399, (Canada) Dr. Xinni Song, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70208


Open to Accrual
ME13L

A Biomarker Sub-study of the CCTG ME.13 Duration of Anti PD-1 Therapy in Metastatic Melanoma STOP-GAP Trial


Complexity Level: 2

Eligibility: Participants of the main ME.13 trial enrolled at a Canadian centre who consent to submit a blood sample for buffy-coat and at least one additional biospecimen category.

Objectives: PRIMARY OBJECTIVE: To profile human bodily material (HBM) before, during and/or post-treatment with immune-checkpoint inhibitors (ICI) to characterize predictive biomarkers of key clinical outcomes of response, progression free and overall survival, and immune related toxicity during continuous and discontinuous ICI therapy regimens from the ME13 clinical trial. SECONDARY OBJECTIVES: (1) To identify spatial relationships between immune and melanoma cells in the pre-treatment tumour microenvironment (TME) that predict clinical outcomes; (2) To define mRNA expression and epigenetic changes in single exhausted CD8+ T cells and other immune cells that correlate with ICI response during continuous vs. intermittent ICI treatment; (3) To determine whether multi-dimensional molecular profiling of melanomas and circulating immune cells can identify a subset of markers to best predict clinical outcomes.

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 14, 2023

Chair: (Canada) Dr. Ian Watson, Canada Research Chair II in Functional Genomics of M, (514) 398-3399


Open to Accrual
ME15 (MASC-MELMART-II)

Melanoma Margins Trial: A Phase III, Multi-centre, Multi-national Randomized Control Trial Investigating 1cm vs 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT-II)

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.


Complexity Level: 2

Eligibility: Patients are eligible if all the following requirements are met: 18 years or older, Histologically confirmed, primary invasive cutaneous melanoma: AJCC 8th edition Stage IIA-IIC (pT2b-pT4b), ECOG performance status 0-1 at randomisation, able to give informed consent, and comply with protocol treatment and follow up, randomisation and treatment must be performed within 120 days of diagnosis, patients must have no previous malignancy or primary except low-risk non-melanoma skin cancer (unless in remission and >5 years since diagnosis).

Objectives: This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition).The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

NCT Registration ID (from clinicaltrials.gov): NCT03860883
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 30, 2020

Chair: (Canada) Dr. Frances C. Wright, Odette Cancer Centre, (416) 480-5000 Ext. 3835


Open to Accrual
MEC6 (ALLIANCE A091903)

A Randomized Phase II Trial of Adjuvant Nivolumab with or without Cabozantinib in Patients with Resected Muscosal Melanoma

Using Nivolumab alone or with Cabozantinib to prevent mucosal melanoma return after surgery


Complexity Level: 2

Eligibility: Histologically proven mucosal melanoma by local pathology; central PD-L1 tissue tumour submission; Resected R0 or R1 disease; non-resected R2 or metastatic disease that is assessable and measurable; no prior systemic checkpoint inhibitor therapy of mucosal melanoma; age 18 or older.

Objectives: To compare the efficacy of adjuvant nivolumab (480mg q4 weeks) versus nivolumab plus cabozantinib (40 mg daily) in patients with mucosal melanoma. The primary objective will be measured as a comparison of duration of recurrence free survival (RFS) between the arms. Secondary objectives: OS, adverse effects by treatment arm, correlation between PD-L1 expresssion in tumour cells with RFS and OS; to evaluate ORR, DOR, PFS and OS of nivo plus cabo in patients who cannot undergo gross total resection of disease or have metastatic disease at baseline.

NCT Registration ID (from clinicaltrials.gov): NCT05111574
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 08, 2022

Chair: (Canada) Dr. Marcus Butler, University Health Network, (416) 946-4501 Ext. 5485


Open to Accrual
ME10 (ECOG E1697)

Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma


Complexity Level: 2

Eligibility: Patients with resected melanoma in the following categories: (1) T3-N0 (1.5-4 mm), (2) T4-N0 (> 4 mm), (3) T1-4 (microscopic, one lymph node positive).

Objectives: To compare the effect of treatment with four weeks of high dose IFN alpha-2b versus observation on relapse free survival and overall survival. Also, toxicities and quality-adjusted survival will be compared in the two groups.

NCT Registration ID (from clinicaltrials.gov): NCT00003641
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 14, 1999 Closing Date: October 26, 2010

Chair: (Canada) Dr. Michael Smylie, Cross Cancer Institute, (780) 432-8757


Closed to Accrual
MEC3 (ECOG E1609)

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma


Complexity Level: 2

Eligibility: Patients enrolled in this study must have a diagnosis of primary cutaneous melanoma (high risk stage IIIB - IV as per AJCC Melanoma Staging System), and must have completely surgically resected disease at baseline. Patients must have been surgically rendered free of disease with negative margins, and must have a disease free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Some patients with disease recurrence after adequate surgical excision of the original primary melanoma are allowed as well, as specified in the protocol. A total of 1500 patients will be enrolled over 3.3 years. Accrual rate is expected to be 38 per month, and with additional follow up time, a total duration of study is expected to be less than 6 years.

Objectives: Primary Objectives: " To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). " To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). Secondary Objectives: " To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).

NCT Registration ID (from clinicaltrials.gov): NCT01274338
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 02, 2012 Closing Date: August 15, 2014

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4270


Closed to Accrual
MEC5 (SWOG 1404)

A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma


Complexity Level: 2

Eligibility: Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years.

Objectives: Primary Objectives: a.Compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) b.Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) c.Compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) d.Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) Secondary Objectives: a. Estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. b. Compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 and treatment arm.

NCT Registration ID (from clinicaltrials.gov): NCT02506153
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 15, 2016 Closing Date: November 02, 2017

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4270


Closed to Accrual
I104

NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 05, 1997 Closing Date: October 26, 1998

Permanently Closed
I137

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma


Eligibility: Patients with malignant melanoma, recurrent and non-curable by surgical or other means. Prior adjuvant immunotherapy permitted. No systemic therapy for relapsed disease (ie, chemotherapy naïve).

Objectives: To determine the efficacy and toxicity of flavopiridol given as a one hour IV infusion daily x three days every three weeks in patients with recurrent/metastatic malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00005971
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2000 Closing Date: July 13, 2001

Permanently Closed
I14

NCIC CTG Phase II Study of N-methylformamide in Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1984 Closing Date: April 29, 1985

Permanently Closed
I156

A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma


Eligibility: Patients with histologically documented malignant melanoma, with metastatic or recurrent disease not curable by other means. Patients may have had prior adjuvant immunotherapy but must NOT have received ANY prior chemotherapy. Disease must be clinically and/or radiologically documented and at least one site of disease must be unidimensionally measurable.

Objectives: To assess the efficacy and toxicity of Perifosine given by mouth for 3 weeks every 4 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00053781
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 16, 2003 Closing Date: April 26, 2004

Permanently Closed
I169

A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma


Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study

Objectives: To assess the efficacy and toxicity of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00095953
Participation: Participation in this phase II study is restricted to invited centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 22, 2004 Closing Date: May 01, 2006

Permanently Closed
I189

A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma


Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study.

Objectives: To assess the efficacy and toxicity of rIL-21 given by IV push for the first 5 days weeks 1, 3 and 5 at 50ug/kg/day in the first 6 previously untreated patients with metastatic or recurrent malignant melanoma. To characterize the pharmacokinetics of rIL-21 when dosed at 50 µg/kg/day. To characterize the effects of rIL-21 on lymphocyte cell-count and soluble CD25 in serum as a potential biomarkers for drug activity. To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. To assess melanoma antigenic markers for response and non progression on archival tissue from patients enrolled on the study.

NCT Registration ID (from clinicaltrials.gov): NCT00514085
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 10, 2007 Closing Date: August 17, 2009

Permanently Closed
I202

A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma


Complexity Level: 2

Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.

Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.

NCT Registration ID (from clinicaltrials.gov): NCT01152788
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2010 Closing Date: February 29, 2012

Permanently Closed
I21

NCIC CTG Phase II Study of Menogaril in Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: March 15, 1986

Permanently Closed
I26

NCIC CTG Phase II Study of Trimetrexate in Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: November 06, 1987

Permanently Closed
I34

NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 13, 1986 Closing Date: May 07, 1987

Permanently Closed
I5

NCIC CTG Phase II Study of Spirogermanium in Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1983 Closing Date: May 14, 1984

Permanently Closed
I56

NCIC CTG Phase II Study of DuP937 in Patients With Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 07, 1991 Closing Date: April 23, 1992

Permanently Closed
I61

NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 08, 1991 Closing Date: January 21, 1992

Permanently Closed
I87

A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 26, 1995 Closing Date: May 01, 1997

Permanently Closed
I91

NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 1995 Closing Date: March 31, 1997

Permanently Closed
ME1

NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 15, 1978 Closing Date: December 31, 1982

Permanently Closed
ME2

NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 11, 1981 Closing Date: June 08, 1982

Permanently Closed
ME3

NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 30, 1982 Closing Date: September 01, 1983

Permanently Closed
ME5

National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 01, 1983 Closing Date: March 16, 1993

Permanently Closed
ME6 (8593)

A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 30, 1986 Closing Date: June 14, 1988

Permanently Closed
ME7

A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis Malignant Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 04, 1988 Closing Date: May 10, 1990

Permanently Closed
ME8

A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic Melanoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 26, 1992 Closing Date: January 31, 1995

Permanently Closed