Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Subjects will have their cancers biopsied and blood samples taken; both will undergo genomic sequencing and analysis

Genome sequencing

Janessa J Laskin, MD

Marco Marra, PhD

Janessa J Laskin, MD, FRCPC

The genomic heterogeneity of cancers implies that to effectively use targeted therapies the investigators will need to assess each individual cancer and match it to a biologically relevant targeted therapy. The investigators will use full genome sequencing to try to identify cancer "drivers" and corresponding drugs that may inhibit these pathways.

Carcinogenesis is an immensely complex process such that even within a histologic cancer subtype - for example adenocarcinoma of the lung or breast - there is significant variability in cancer behaviour and response to therapy. Analyses of individual patients demonstrate unique molecular signatures for every cancer examined. Frequently, multiple different pathways are involved in disease growth and progression and the dominant process varies from person to person and perhaps even within different sites of disease within one person. As well these variations evolve in response to treatment.

Recognizing genetic aberrations that promote disease facilitates targeted treatment; this has been demonstrated in several small subgroups of cancers in which specific genetic mutations or translocations have been successfully treated with targeted chemotherapy agents. With many recognized mutations and aberrations, personalized evaluation of the genetic signature encoded in DNA and RNA may provide important diagnostic information and potentially enable directed therapy to the appropriate oncologic pathway thereby providing information to help guide chemotherapy choices

Our initial pilot project demonstrated the feasibility of this approach at our institution (with 100 patients). We now know it is possible to identify and consent patients, sequence the genome and transcriptome, analyze and report abnormalities, and identify potential actionable targets in a clinically relevant time frame.

The Personalized OncoGenomics (POG) program has been operational across the province of BC since 2012. The initial two-year phase established the infrastructure and workflow by which patients with metastatic or incurable cancers could be identified, consented, and biopsied for genomic sequencing in a clinically accredited lab (Laskin et al., 2015). The next phase of the POG program (2014 - 2017) included a strong educational and engagement process such that 83 (80%) of the medical oncologists at BC Cancer were trained to consent and enroll patients onto POG. This means that the oncology community in BC has a broad education in cancer genomics and how these data may be applied to individual patients. Since 2017, the program has been integrated into the Vancouver Cancer Centre's phase 1 clinical trials unit and the focus has shifted to use the study patients and data to address more focused clinical therapeutic trials such as the CCTG CAPTUR study (Skamene et al., 2018). POG-like WGTA has been the driving force behind the creation of the Terry Fox Marathon of Hope Cancer Centre Network (MOHCCN) which is a national program for cancer genomic data sharing across Canada.

The overarching theme of this POG Program is to create a comprehensive cataloguing of somatic cancer mutations and cellular pathway abnormalities that could generate profound insights into genetic patterns that underlie particular cancer phenotypes, and provide valuable prognostic and predictive information.

Eligible subjects will have several samples analyzed: a fresh tumour biopsy (typically 5 cores are required), a blood sample for normal comparison and archival tumours when available. Also, technology has improved such that we may consider using paraffin embedded materials. Comprehensive DNA and RNA sequencing is performed followed by an in-depth bioinformatic analysis to identify somatic mutations, gene expression changes or other abnormalities that might be cancer "drivers" or provide actionable (diagnostic) or druggable targets. The POG team meets every week to discuss the detailed genomic reports for patients, consider additional validation tests when necessary, and debate research questions. The clinicians (typically 5 - 10) come to a consensus on what systemic therapies might be appropriate based on these results. Whenever possible subjects are matched to clinical trials.

Personalized Oncogenomics (POG) Program of British Columbia

Personalized OncoGenomics (POG) Program of British Columbia: Connecting Cancer Genomics to Cancer Care

This outcome will allow us to study how often in-depth genomic data impacts on clinical decision-making in a general oncology population. It will help describe how useful or important this sort of data is in daily practice.

Accumulation of genomic information linked to treatment/outcome data will greatly enhance our knowledge and understanding of cancers and response to treatment.

BC Cancer Foundation

British Columbia Cancer Agency

Fatigue

Neoplasms, Second Primary

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Participants in the PI group will complete the educational sessions only.

Psychoeducational Intervention

This group will only take placebo capsules every day.

Open Label Placebo

This group will take the placebo capsules every day, as well as completing the educational sessions.

Psychoeducational Intervention+Placebo

Sriram Yennu, MD

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Primary Objectives:

1. To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.

We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.

Secondary Objectives:

1. To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment

3. To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).

We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

M.D. Anderson Cancer Center

Anti-Infective Agents

Antirheumatic Agents

All Drugs and Chemicals

Antineoplastic Agents

Hydroxychloroquine

Sirolimus

Vorinostat

Temsirolimus

MTOR Inhibitors

Histone Deacetylase Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Hydroxychloroquine starting dose of 200 mg by mouth every day for a 21 day cycle. Sirolimus starting dose of 2 mg by mouth every day for a 21 day cycle.

Hydroxychloroquine starting dose of 200 mg by mouth every day for a 21 day cycle. Vorinostat starting dose of 200 mg by mouth per day for a 21 day cycle.

Starting dose of 200 mg by mouth every day for a 21 day cycle.

Starting dose of 2 mg by mouth every day for a 21 day cycle.

Starting dose of 200 mg by mouth per day for a 21 day cycle.

Filip Janku, MD, PHD

The goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The safety of these drug combinations will also be studied.

Study Drug Dose Level:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of hydroxychloroquine and either sirolimus or vorinostat, based on when you joined this study, availability of spots for each drug combination, and what your doctor thinks is in your best interest. Up to 11 dose levels of the sirolimus and hydroxychloroquine combination and 7 dose levels of the vorinostat and hydroxychloroquine combination will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of each drug combination is found.

Once the highest tolerated dose of each drug combination is found, up to 28 more participants (14 per combination) will be given this dose. The study doctor will decide which drug combination each participant is given, based on their tumor type.

Study Drug Administration:

Each study "cycle" is 21 days.

You will take hydroxychloroquine and either vorinostat or sirolimus by mouth, 1 time a day, every day. You should take the pills at about the same time each day with food and a cup (8 ounces) of water.

Study Visits:

At every study visit, you will be asked about any health conditions you have, drugs you may be taking, and if you have had any side effects.

Weekly During Cycle 1:

° Blood (about 2 teaspoons) will be drawn for routine tests.

At the beginning of each cycle beginning with 2:

* You will have a physical exam.
* Your medical history will be recorded.
* You will be asked if you have any muscle weakness or difficulty while moving.

Every 6 weeks, you will have an x-ray, CT scan, MRI scan, and/or PET/CT to check the status of the disease. If the study doctor thinks it is needed, they will be performed more often. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

About every 3 months, you will have an eye exam.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.

This is an investigational study. Sirolimus is FDA approved and commercially available for the treatment of patients with a kidney transplant. Vorinostat is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma. Hydroxychloroquine is FDA approved and commercially available to treat malaria. The use of these drugs combinations is investigational.

Up to 224 patients will take part in this study. All will be enrolled at MD Anderson.

Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer

A Phase I Trial of Sirolimus (mTOR Inhibitor) or Vorinostat (HDAC Inhibitor) in Combination With Hydroxychloroquine (Autophagy Inhibitor) in Patients With Advanced Malignancies

Maximum tolerated dose (MTD) defined defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first treatment cycle.

Dose limiting toxicity (DLT) defined as: Any grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v3.0 that is possibly, probably or definitely related to any of the three study medications, even if expected. This is to include symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is possibly, probably or definitely related to the therapy.

Participants with lymphoma measured per the WHO criteria,68 and all others evaluated using RECIST 1.1 criteria.69.

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Stomach Neoplasms

Lung Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Immunomodulating Agents

All participants will receive gene modified T cells, with concomitant IL2 for 30 days post infusion.

Subjects will undergo T cell leukopheresis. The collected T cells will be genetically modified, and then re-infused peripherally. IL2 will be given concomitantly for 30 days post modified T cell infusion via CADD pump.

Gene Modified T Cells

Richard P Junghans, PhD, MD

T cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remis-sions of cancer. However, T cells are easily tolerized to self or tumor antigens and "immune surveillance" has manifestly failed in every cancer that is clinically apparent. It is the goal of these studies to supply the specificities and affinities to patient T cells without regard for their "endogenous" T cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. This extends the approach of Anderson, Rosenberg and co-workers to introduce or augment expression of genes in patients' T cells in a therapeutic setting.

Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. The target antigen for these studies is carcinoembryonic antigen (CEA) which is predominantly expressed on tumors of the colon and rectum, breast, pancreas and other sites.

CEA is perhaps the most prominent tumor marker among malignancies of epithelial origin: colorectal carcinoma, with 60-94% of tumors positive in patients with advanced disease; breast carcinoma, with 30-60% of metastatic cases positive for CEA; and cancers of the lung, liver, pancreas, head and neck, bladder, cervix and prostate with 30% or more with CEA+ tumors.

The application of these therapies in the four Phase II/Pilot clinical sub studies listed below proceed after collecting patient lymphocytes by leukapheresis, which are then modified by transfer of the chimeric gene for Ig-CD28-TCRzeta. Cells are selected in culture with amplification and activation of the now-specific anti-tumor T cells. These are then re infused into the patients, with IL2 supplementation, and toxicity and response are monitored.

There are four sub studies embedded within this Phase II Study of Second Generation Designer T Cells in CEA-expressing Adenocarcinomas. The embedded studies are:

* A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Gastric Cancers (CEA-G)
* A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Colorectal Cancers (CEA-C)
* A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Lung Cancers (CEA-L)
* A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Solid Tumors (CEA-S)

A total of 12 subjects per protocol or a total of 48 subjects will be enrolled combining the enrollment of the 4 CEA-expressing protocols.

Phase II/Pilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas

"Phase II/Pilot Study of 2nd Generation Anti-CEA Esigner T Cells in Adenocarcinomas"

Monitoring of CEA levels, pre and post infusion of T cells. Monitoring of CT and PET scans pre and post infusion.

Monitoring and recording of all adverse and serious adverse events using CTC 4.0 criteria.

Roger Williams Medical Center

Principal Investigator

In this study, we aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. We will focus our analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed

In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies.

The investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed

In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. the investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed

Blood sampling

Charles Ferté, MD PhD

Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

The primary endpoint is the rate of patients with tumors harboring a low level of genomic alteration (mutation, amplification or deletion) in genes (i.e. mutation, amplification, deletion) identified as causally implicated in cancer. A low level of genomic alteration is defined by the presence of less than the 5th quantile of genomic alterations to be expected in the given tumor type. Conversely, a high level of genomic alteration is defined by the presence of more than the 5th quantile of genomic alterations to be expected in the given tumor type.

The list of genes for which alterations are identified as causally implicated in cancer is defined by the Cancer Gene Census. This is an ongoing effort to catalogue those genes for which mutations, amplifications or deletions have been causally implicated in cancer. It is constantly updated by the Wellcome Trust Sanger Institute (UK) and available at: http://cancer.sanger.ac.uk/census (n=571 genes in September 2015)

EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies

Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors

UNICANCER

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Amino Acids

Mitogens

Vemurafenib

Protein Kinase Inhibitors

Serine

Threonine

Valine

all eligible patients entering the study will receive oral Vemurafenib as monotherapy.

Vemurafenib ZELBORAF 240 mg tablets Per OS 960 mg twice daily, to a total daily dose of 1,920 mg Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks Safety will be assessed continuously

Treatment will be pursed until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient refusal.

Vemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation

Jean-Yves PI Blay, MD

Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.

To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.

This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent vemurafenib as a monotherapy in cohorts of patients with identified activating molecular alterations in BRAF gene. A cohort is defined by a pathology and a BRAF- alteration (eg ovarian cancer with BRAF V600 mutation).

To explore the efficacy of vemurafenib per pathology and per target. To assess the safety profile of vemurafenib. To explore whether molecularly driven, high quality multi-tumor screening phase II trials are feasible in the French multiinstitutional, multidisciplinary setting.

To investigate the additional molecular mechanisms in patients with tumor response versus patients without tumor response within the same cohort.

The study will include 11 cohorts of adult patients with the following cancers and alterations:

* NSCLC V600 mutated
* Ovarian cancer V600 mutated
* Cholangiocarcinoma V600 mutated
* Thyroid cancer V600 mutated
* Prostatic cancer V600 mutated
* Bladder cancer V600 mutated
* Sarcoma/GIST V600 mutated
* Multiple myeloma V600 mutated
* Chronic Lymphocytic Leukemia (CLL) V600 mutated
* Hairy cell leukaemia (HCL) V600 mutated (this excludes Hairy Cell Leukemia variant types, marginal zone splenic lymphoma (MZL), splenic red pulp lymphoma (SRPL) patients)
* Other pathology / other alteration than those pre-defined above.

The cohort named "Other" will include adult patients with tumor harboring BRAF genomic alterations only tested via emerging biomarkers programs or molecular pangenomic programs:

* with any other non-predefined pathology harboring a V600 mutation
* Same or other non-predefined pathology harboring non V600 activating mutations
* Same or other non-predefined pathology harboring BRAF amplifications.

Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

RECIST for solid tumors, International Myeloma Working Group Response Criteria for myeloma, IWCLL for CLL, clinical exam, blood tests (blood count) and bone marrow exam for Hairy Cell Leukemia.

The assessment of safety will be based mainly on the frequency of adverse events coded using the common toxicity criteria (CTC-V4.0) grade.

National Cancer Institute, France

Fondation ARC

Hoffmann-La Roche

Antibodies

Lenalidomide

Ipilimumab

Immunoglobulins

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Dose Escalation Group Ipilimumab Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle.

Dose Escalation Group Lenalidomide Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle.

Dose Expansion Group Starting Dose for Ipilimumab and Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Groups.

Dose Escalation Group Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle.

Dose Expansion Group Starting Dose for Ipilimumab: Maximum tolerated dose (MTD) from Dose Escalation Group.

Dose Escalation Group Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle.

Dose Expansion Group Starting Dose for Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Group.

The goal of this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.

Ipilimumab is designed to increase the immune system's ability to fight cancer.

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

Study Groups:

Dose escalation:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drugs based on when you join the study.

Up to 5 dose levels of ipilimumab with lenalidomide will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ipilimumab with lenalidomide is found.

Dose expansion:

Once the highest tolerable dose of ipilimumab with lenalidomide is found, up to 14 more participants may be enrolled. This will be to further study the safety of the combination of drugs at that dose and the level of effectiveness of the study drugs in a certain tumor group. This group will be called the dose expansion group.

Study Drug Administration:

Each study cycle is 28 days.

You will take lenalidomide by mouth on Days 1-21 of each cycle. You will swallow the capsules whole with water once a day. Do not break, chew, or open your capsules. The doctor will discuss this with you.

You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle. You will be monitored for side effects for 1-2 hours after the infusion.

Study Visits:

Every study visit:

° You will be asked if you have had any side effects.

Cycle 1:

* On Day 1: blood (about 4 teaspoons) will be drawn for routine tests.
* Between Days 2 and 7: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
* Between Days 8 and 14: Blood (about 4 teaspoons) will be drawn for routine tests. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
* Between Days 15 and 21: Blood (about 4 teaspoons) will be drawn for routine tests. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
* Between Days 22 and 28: Blood (about 4 teaspoons) will be drawn for routine tests. Your medical history will be recorded.

Cycle 2:

* On Day 1: Blood (about 4 teaspoons) will be drawn for routine tests.
* On Day 8 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
* On Day 15 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
* On Day 22 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.

Every other cycle (every 8 weeks):

° You will have an x-ray, CT scan, and/or PET/CT scan to check the status of the disease. ° Blood (about 1 tablespoon) will be drawn for tumor marker testing.

Before starting Cycle 3 and all following cycles:

* Your medical history will be recorded.
* You will have a physical exam, including measurement of your weight and vital signs.
* You will be asked about any health problems you may have and any other drugs or herbal supplements you may be taking.
* Your performance status will be recorded.
* Blood (about 4 teaspoons) will be drawn for routine tests. Blood may be drawn more often if your doctor thinks it is needed.
* If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

At the End of the study:

* Directly at the end of the study: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
* 28 days after therapy with lenalidomide stopped: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Length of Dosing:

You may receive up to 4 doses of ipilimumab. You may continue receiving lenalidomide for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You will be off study after your follow-up visit.

Follow-up:

You will have a follow-up-visit within 30 days after your last dose of study drugs. You will be asked about any health problems you may have and if you have had any side effects. If your study doctor thinks it is needed, you may have follow-up for a longer period of time. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

This is an investigational study. Ipilimumab is FDA approved and commercially available to treat metastatic melanoma. Lenalidomide is FDA approved and commercially available to treat multiple myeloma and myelodysplastic syndrome. Giving the combination of ipilimumab and lenalidomide to patients with advanced cancer is investigational.

Up to 101 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Ipilimumab and Lenalidomide in Advanced Cancer

A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies

Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.

Dose-limiting toxicity (DLT) defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0, expected and believed to be related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 hematologic toxicity lasting at least 3 weeks or longer (as defined by the NCI-CTC v4.0) or associated with bleeding and/or sepsis; any grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE v4.0 that is attributable to the therapy.

Rumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a \>/= 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Oncogenomics (POG) Program of British Columbia	NCT02155621	Metastatic Canc... Advanced Cancer... Cancers That Ca...	Genome sequenci...	18 Years - 85 Years	British Columbia Cancer Agency
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center
Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer	NCT01266057	Advanced Cancer...	Hydroxychloroqu... Sirolimus Vorinostat	18 Years -	M.D. Anderson Cancer Center
Phase II/Pilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas	NCT01723306	Metastatic Canc...	Gene Modified T...	18 Years - 80 Years	Roger Williams Medical Center
EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies	NCT02701907	Metastatic Canc...	Blood sampling	18 Years -	UNICANCER
Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations	NCT02304809	Solid Tumors Hematologic Can... Metastatic Canc...	Vemurafenib	18 Years -	UNICANCER
Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer	NCT01266057	Advanced Cancer...	Hydroxychloroqu... Sirolimus Vorinostat	18 Years -	M.D. Anderson Cancer Center
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center
Phase II/Pilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas	NCT01723306	Metastatic Canc...	Gene Modified T...	18 Years - 80 Years	Roger Williams Medical Center
Ipilimumab and Lenalidomide in Advanced Cancer	NCT01750983	Advanced Cancer...	Ipilimumab Lenalidomide	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastatic cancers