An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate548)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02667587 |
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Recruitment Status :
Recruiting
First Posted : January 29, 2016
Last Update Posted : July 31, 2018
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Neoplasms | Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy Other: Nivolumab Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 693 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma |
| Actual Study Start Date : | May 5, 2016 |
| Estimated Primary Completion Date : | February 11, 2022 |
| Estimated Study Completion Date : | August 1, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Brain Tumors
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nivolumab + Temozolomide + Radiotherapy
Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
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Drug: Nivolumab
Other Names:
Drug: Temozolomide Other Names:
Radiation: Radiotherapy Other Name: RT |
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Placebo Comparator: Nivolumab placebo + Temozolomide + Radiotherapy
Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks
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Drug: Temozolomide
Other Names:
Radiation: Radiotherapy Other Name: RT Other: Nivolumab Placebo |
Primary Outcome Measures :
- Overall survival (OS) defined as time from the date of randomization to the date of death. [ Time Frame: Approximately 69 months after first patient first visit ]
Secondary Outcome Measures :
- Progression free survival (PFS), defined as the time from randomization to the date of the first documented tumor progression or death to any cause. [ Time Frame: Approximately 69 months after first patient first visit ]
- Correlation of PFS and OS [ Time Frame: Approximately 69 months after first patient first visit ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Males and Females, age ≥ 18 years old
- Newly diagnosed brain cancer or tumor called glioblastoma or GBM
- Karnofsky performance status of ≥ 70 (able to take care of self)
- Substantial recovery from surgery resection
- Tumor test result shows MGMT methylated or indeterminate tumor subtype
Exclusion Criteria:
- Biopsy-only of GBM with less than 20% of tumor removed
- Prior treatment for GBM (other than surgical resection)
- Any known tumor outside of the brain
- Recurrent or secondary GBM
- Active known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667587
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
| Contact: First line of the email MUST contain NCT# and Site #. |
Hide Study Locations
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294-3410 | |
| Contact: Louis Nabors, Site 0023 205-934-1842 | |
| United States, Arizona | |
| St. Joseph Hospital And Medical Center | Active, not recruiting |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Cedars Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Jeremy Rudnick, Site 0026 310-423-4513 | |
| UCLA Neuro-Oncology Program | Recruiting |
| Los Angeles, California, United States, 90095-1769 | |
| Contact: Timothy Cloughesy, Site 0010 310-794-3521 | |
| Sutter Institute For Medical Research | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Stacy Dandre, Site 0128 916-453-5800 | |
| Sharp Memorial Hospital | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Charles Redfern, Site 0029 619-502-3241 | |
| The Regents of the University of California, San Francisco | Active, not recruiting |
| San Francisco, California, United States, 94143-0372 | |
| United States, Connecticut | |
| Yale University School Of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Joachim Baehring, Site 0004 203-785-7486 | |
| United States, District of Columbia | |
| Georgetown University | Active, not recruiting |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| University Of Miami Sylvester Comprehensive Cancer Center | Active, not recruiting |
| Miami, Florida, United States, 33136 | |
| Moffitt Cancer Center | Active, not recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Local Institution | Not yet recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Site 0022 | |
| United States, Kansas | |
| University Of Kansas Medical Center | Recruiting |
| Westwood, Kansas, United States, 66205 | |
| Contact: Michael Salacz, Site 0060 913-588-1886 | |
| United States, Kentucky | |
| Norton Cancer Institute | Active, not recruiting |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Johns Hopkins University School Of Medicine | Active, not recruiting |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: David Reardon, Site 0028 617-632-4876 | |
| Local Institution | Withdrawn |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: David Reardon, Site 0011 617-643-1933 | |
| United States, Michigan | |
| Henry Ford Health System | Active, not recruiting |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Washington University School Of Medicine | Active, not recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| JFK Medical Center | Active, not recruiting |
| Edison, New Jersey, United States, 08820-3947 | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Samuel Goldlust, Site 0012 551-996-5098 | |
| United States, New York | |
| Columbia University | Active, not recruiting |
| New York, New York, United States, 10032 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Mariza Daras, Site 0024 212-610-0239 | |
| United States, North Carolina | |
| Levine Cancer Institute | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Ashley Sumrall, Site 0032 980-442-5300 | |
| Preston Robert Tisch Brain Tumor Center at Duke University | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | Active, not recruiting |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University Wexner Medical Center | Active, not recruiting |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Lehigh Valley Health Network | Active, not recruiting |
| Allentown, Pennsylvania, United States, 18103 | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Lyndon Kim, Site 0016 215-503-9110 | |
| United States, South Carolina | |
| Medical University Of South Carolina | Active, not recruiting |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Erlanger Oncology & Hematology - Univ. of TN | Active, not recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Vanderbilt University Medical Center | Active, not recruiting |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University Of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Edward Pan, Site 0025 214-648-1929 | |
| Local Institution | Withdrawn |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Adam Cohen, Site 0009 801-587-4433 | |
| United States, Washington | |
| Swedish Neuroscience Institute | Active, not recruiting |
| Seattle, Washington, United States, 98122 | |
| Australia, New South Wales | |
| Local Institution | Active, not recruiting |
| Liverpool, New South Wales, Australia, 2017 | |
| Royal North Shore Hospital | Active, not recruiting |
| St. Leonards, New South Wales, Australia, 2065 | |
| Australia, Victoria | |
| Local Institution | Active, not recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Local Institution | Active, not recruiting |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | Active, not recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Austria | |
| Kepler Universitaetsklinikum | Active, not recruiting |
| Linz, Austria, 4020 | |
| Medical University Of Vienna | Active, not recruiting |
| Vienna, Austria, 1090 | |
| Belgium | |
| Universitair Ziekenhuis Brussel | Recruiting |
| Brussels, Belgium, 1090 | |
| Contact: Bart Neyns, Site 0070 +3224775457 | |
| Cliniques Universitaires Saint-Luc | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Nicolas Whenham, Site 0069 +3210437147 | |
| Uz Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Paul Clement, Site 0071 +3216346903 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency-Vancouver Ctr | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Brian Thiessen, Site 0046 6048776000 | |
| Canada, Ontario | |
| Princess Margaret Cancer Centre | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Warren Mason, Site 0048 4165817823 | |
| Canada, Quebec | |
| Montreal Neurological Institute and Hospital | Recruiting |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Contact: Kevin Petrecca, Site 0047 5143982801 | |
| Denmark | |
| Local Institution | Active, not recruiting |
| Copenhagen, Denmark, 2100 | |
| Local Institution | Active, not recruiting |
| Odense, Denmark, 5000 | |
| France | |
| Local Institution | Recruiting |
| Lille Cedex, France, 59037 | |
| Contact: Site 0043 | |
| Local Institution | Recruiting |
| Lyon Cedex 03, France, 69394 | |
| Contact: Site 0041 | |
| Local Institution | Recruiting |
| Marseille, France, 13385 | |
| Contact: Site 0040 | |
| Local Institution | Recruiting |
| Nancy, France, 54035 | |
| Contact: Site 0042 | |
| Local Institution | Recruiting |
| Paris cedex 13, France, 75651 | |
| Contact: Site 0039 | |
| Local Institution | Recruiting |
| Paris, France, 75010 | |
| Contact: Site 0038 | |
| Local Institution | Recruiting |
| Rennes Cedex, France, 35042 | |
| Contact: Site 0044 | |
| Local Institution | Recruiting |
| Toulouse, France, 31100 | |
| Contact: Site 0045 | |
| Germany | |
| Universitaetsklinikum Bonn | Active, not recruiting |
| Bonn, Germany, 53105 | |
| Uniklinik Erlangen | Active, not recruiting |
| Erlangen, Germany, 91054 | |
| Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main | Active, not recruiting |
| Frankfurt Am Main, Germany, 60528 | |
| Universitaetsklinikum Freiburg | Active, not recruiting |
| Freiburg, Germany, 79106 | |
| Universitaetsklinikum Hamburg | Active, not recruiting |
| Hamburg, Germany, 20246 | |
| Universitaetsklinik Heidelberg | Active, not recruiting |
| Heidelberg, Germany, 69120 | |
| Universitaetsklinik Koeln | Active, not recruiting |
| Koeln, Germany, 50937 | |
| Universitaetsklinikum Muenster | Active, not recruiting |
| Muenster, Germany, 48149 | |
| Klinikum rechts der Isar der Technischen Universitat Munchen | Active, not recruiting |
| Munich, Germany, 81675 | |
| Bezirksklinikum Regensburg | Active, not recruiting |
| Regensburg, Germany, 93053 | |
| Universitasklinikum Tubingen | Active, not recruiting |
| Tuebingen, Germany, 72076 | |
| Israel | |
| Local Institution | Active, not recruiting |
| Petach Tikva, Israel, 49100 | |
| Local Institution | Active, not recruiting |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Local Institution | Active, not recruiting |
| Bologna, Italy, 40139 | |
| Local Institution | Active, not recruiting |
| Milano, Italy, 20133 | |
| Local Institution | Active, not recruiting |
| Padova, Italy, 35128 | |
| Local Institution | Active, not recruiting |
| Rozzano (milano), Italy, 20089 | |
| Local Institution | Active, not recruiting |
| Siena, Italy, 53100 | |
| Local Institution | Active, not recruiting |
| Torino, Italy, 10126 | |
| Japan | |
| Local Institution | Recruiting |
| Nagoya-shi, Aichi, Japan, 4668560 | |
| Contact: Site 0110 | |
| Local Institution | Recruiting |
| Chiba-shi, Chiba, Japan, 2600856 | |
| Contact: Site 0099 | |
| Local Institution | Recruiting |
| Hiroshima-Shi, Hiroshima, Japan, 7348551 | |
| Contact: Site 0100 | |
| Local Institution | Recruiting |
| Sapporo-shi, Hokkaido, Japan, 0608648 | |
| Contact: Site 0101 | |
| Local Institution | Recruiting |
| Kobe-shi, Hyogo, Japan, 650-0017 | |
| Contact: Site 0105 | |
| Local Institution | Recruiting |
| Tsukuba-shi, Ibaraki, Japan, 3058576 | |
| Contact: Site 0116 | |
| Local Institution | Recruiting |
| Kanazawa-shi, Ishikawa, Japan, 9200934 | |
| Contact: Site 0103 | |
| Local Institution | Recruiting |
| Kagoshima-shi, Kagoshima, Japan, 8908520 | |
| Contact: Site 0102 | |
| Local Institution | Recruiting |
| Sagamihara-shi, Kanagawa, Japan, 2520375 | |
| Contact: Site 0118 | |
| Local Institution | Recruiting |
| Kumamoto-shi, Kumamoto, Japan, 8608556 | |
| Contact: Site 0106 | |
| Local Institution | Recruiting |
| Kyoto-shi, Kyoto, Japan, 6128555 | |
| Contact: Site 0108 | |
| Local Institution | Recruiting |
| Okayama-shi, Okayama, Japan, 7000914 | |
| Contact: Site 0120 | |
| Local Institution | Recruiting |
| Hirakata-shi, Osaka, Japan, 5731191 | |
| Contact: Site 0104 | |
| Local Institution | Recruiting |
| Suita-shi, Osaka, Japan, 5650871 | |
| Contact: Site 0112 | |
| Local Institution | Recruiting |
| Hidaka-shi, Saitama, Japan, 3501298 | |
| Contact: Site 0121 | |
| Local Institution | Recruiting |
| Bunkyo-ku, Tokyo, Japan, 1138655 | |
| Contact: Site 0114 | |
| Local Institution | Recruiting |
| Chuo-ku, Tokyo, Japan, 1040045 | |
| Contact: Site 0111 | |
| Local Institution | Recruiting |
| Mitaka-shi, Tokyo, Japan, 181-8611 | |
| Contact: Site 0107 | |
| Local Institution | Recruiting |
| Shinjuku-ku, Tokyo, Japan, 1628666 | |
| Contact: Site 0115 | |
| Local Institution | Recruiting |
| Yamagata-shi, Yamagata, Japan, 9909585 | |
| Contact: Site 0117 | |
| Local Institution | Recruiting |
| Kyoto, Japan, 6068507 | |
| Contact: Site 0109 | |
| Netherlands | |
| NKI AVL | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Contact: Dieta Brandsma, Site 0075 +31205122570 | |
| Universitair Medisch Centrum Groningen | Recruiting |
| Groningen, Netherlands, 9713 AP | |
| Contact: Annemiek Walenkamp, Site 0074 +31503616161 | |
| Erasmus Mc | Recruiting |
| Rotterdam, Netherlands, 3015 CE | |
| Contact: Martin Van Den Bent, Site 0073 +31107041415 | |
| Universitair Medisch Centrum Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Filip De Vos, Site 0072 +31887556263 | |
| Norway | |
| Local Institution | Active, not recruiting |
| Oslo, Norway, 0424 | |
| Poland | |
| Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote | Recruiting |
| Gdansk, Poland, 80-952 | |
| Contact: Renata Zaucha, Site 0086 +48583492257 | |
| Klinika Nowotworow Glowy i Szyi | Recruiting |
| Warszawa, Poland, 02-781 | |
| Contact: Andrzej Kawecki, Site 0132 +48693824485 | |
| Russian Federation | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 105229 | |
| Contact: Site 0095 | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 115478 | |
| Contact: Site 0097 | |
| Local Institution | Withdrawn |
| Moscow, Russian Federation, 125047 | |
| Spain | |
| Local Institution | Active, not recruiting |
| Badalona-barcelona, Spain, 08916 | |
| Local Institution | Active, not recruiting |
| Barcelona, Spain, 08035 | |
| Local Institution | Active, not recruiting |
| Barcelona, Spain, 08036 | |
| Local Institution | Active, not recruiting |
| Madrid, Spain, 28009 | |
| Local Institution | Active, not recruiting |
| Madrid, Spain, 28041 | |
| Local Institution | Active, not recruiting |
| Santiago Compostela, Spain, 15706 | |
| Local Institution | Active, not recruiting |
| Valencia, Spain, 46014 | |
| Sweden | |
| Local Institution | Active, not recruiting |
| Lund, Sweden, 221 85 | |
| Local Institution | Active, not recruiting |
| Solna, Sweden, 171 64 | |
| Switzerland | |
| University Hospital Geneva | Active, not recruiting |
| Geneve, Switzerland, 1211 | |
| Centre hospitalier universitaire Vaudois (CHUV) | Active, not recruiting |
| Lausanne, Switzerland, 1011 | |
| UniversitaetsSpital Zurich | Active, not recruiting |
| Zuerich, Switzerland, 8091 | |
| United Kingdom | |
| University College Hospital | Recruiting |
| London, Greater London, United Kingdom, NW1 2PG | |
| Contact: Paul Mulholland, Site 0067 +444473809358 | |
| Christie Hospital Nhs Found. Trust | Recruiting |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| Contact: Catherine Mcbain, Site 0066 +441614463000 | |
| Royal Marsden Hospital | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Liam Welsh, Site 0119 | |
| Beaston West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Contact: Stefan Nowicki, Site 0068 +441413017000 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02667587 History of Changes |
| Other Study ID Numbers: |
CA209-548 2015-004722-34 ( EudraCT Number ) |
| First Posted: | January 29, 2016 Key Record Dates |
| Last Update Posted: | July 31, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Glioblastoma Nivolumab Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Temozolomide Dacarbazine Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |