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ProtocolTrial Name and Objective
081203

Autophagy inhibition to augment mTOR inhibition: A phase I/II trial of RAD001 and hydroxychloroquine in patients with previously treated renal cell carcinoma

Primary Objective Phase I
To determine the maximum tolerated dose of HCQ when administered with daily RAD001 in patients with advanced RCC.
Primary Objective Phase II

To estimate the rate of 6 month PFS in RCC patients receiving RAD001 and HCQ who have had between 1 and 3 prior treatment regimens for advanced disease.

Secondary Objectives
1) To estimate the response rate of this combination.
2) To measure evidence of autophagy inhibition by EM and LC3, p62 immunoblotting in PBMC and tumor tissue
3) To define significant associations between baseline composite p-p70S6K/pAKt score (14) and PFS or response. To characterize significant associations between baseline genetic mutations and outcome and associations between baseline expression of LC3, p62, ATG5 and Beclin and clinical outcome.
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051403

A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Dose escalation:
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks

Dose expansion:
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
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081403

Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer

To determine the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed clinical TxN1Mx or TxNxM1 prostate cancer (herein, collectively referred to as metastatic prostate cancer).

Time to PSA nadir and castration resistance following cytoreductive prostatectomy and
subsequent standard systemic therapy, androgen deprivation.
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051407

A continuation clinical trial of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Primary Objectives
To evaluate the long-term safety and tolerability of ONC201 administered orally in patients with advanced cancers.

Secondary Objectives
1. To characterize pharmacokinetics of ONC201.

2. To assess serum biomarkers of therapeutic response to ONC201.

3. To assess preliminary antitumor activity of ONC201 as a single agent in advanced solid tumors
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011201

CC-122-ST-001: A Phase IA/IB, Multi-center,Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotrophic Pathway modifier CC-122 administered orally to subjects with advanced solid tumors, NHL and Multiple Myeloma.

Primary Objectives:
1. To determine the safety and tolerability of CC-122 given orally and to define the non-tolerable dose, MDT and the recommended phase 2 dose.
2. To determine the PK and extent of urinary excretion of CC-122.
Secondary Objectives:
1. Preliminary assessment of the anti-tumor activity of CC-122.
2. To determine the CNS penetration of CC-122.
3. To evaluate the PD effects of CC-122 on gene expression, cytoskeletal structure and cell surface organization in peripheral blood cell components.
4. To evaluate modulation of circulating cytokines in the plasma.
5. To evaluate modulation of immune effector cells and their subtypes in peripheral blood.
6. To evaluate the modulation of cytokine production in ex vivo LPS and anti-CD3 stimulated peripheral blood.
7. To determine the plasmacogenomic relationship between tumor gene sequence or copy number and response.
8. To explore the relationship between PK and PD effects of CC-122.
9. To explore the effect of CC-122 on biomarkers of angiogenesis in pre-and during treatment tumor biopsies when available.
10. To characterize the principle metabolites of CC-122 in plasma and urine.
11.To determine the PK of CC-122 anantiomers in urine and plasma.
12. To assess relationship between renal function and the PK of CC-122.
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051302

JNJ-42756493: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

1) To determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation)
2) To evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous celllung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion)
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051306

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

To assess the safety and tolerability of MSB0010718C and to determine the maximum tolerated dose (MTD) of MSB0010718C in subjects with metastatic or locally advanced solid tumors.
Secondary objectives
- To characterize the pharmacokinetic (PK) profile of MSB0010718C and to correlate exposure with target occupancy.
- To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure
and biological activity.
- To assess the best overall response (BOR) andprogression-free survival time (PFS) according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1.
- To assess the immune-related BOR (irBOR) and immune-related PFS (irPFS) using the modified Immune-Related Response Criteria (irRC),
derived from RECIST 1.1.
- To assess overall survival time (OS).
- To evaluate biological responses to MSB0010718C in blood/serum.
- To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and BOR.
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051404

NCI/CTEP #8808: An Early Phase I Study of ABT-888 in Combination with Carboplatin and Paclitaxel in Patients with Hepatic or Renal Dysfunction and Solid Tumors

Primary Objectives: (1) to determine the pharmacokinetics and pharmacodynamics of ABT-888 in patients with varying degrees of renal or hepatic dysfunction. (2) to determine the maximum tolerated dose (MTD) of ABT-888 in combination with carboplatin and paclitaxel for patients with varying degrees of liver or kidney function. (3) to provide dosing recommendations for ABT-888 in combination with carboplatin and paclitaxel based on degree of hepatic and renal impairment.
Seconday Objectives: (1) to define the dose-limiting toxicity and other toxicities associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction. (2) to evaluate the pharmacokinetic parameters of ABT-888, carboplatin and paclitaxel when administered as a combination in patients with varying degrees of renal or hepatic dysfunction. (3) to evaluate the pharmacodynamic measurement of PAR and platinum adducts in tumor cells associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction.
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051405

A Phase I Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex, in Patients with Advanced Melanoma

Primary Objectives: (1) to study the safety of escalating doses of ALT-803 in patients with advanced melanoma and screen the selected dose in an expansion cohort for evidence of antitumor activity. (2) to evaluate the effect of escalating doses of ALT-803 on the peripheral blood white blood cell (WBC) and absolute lymphocyte (ALC) counts.
Secondary Objectives: To evaluate the effect of escalating doses of ALT-803 on: (1) the number and phenotype of peripheral blood mononuclear cells (PBMCs), including T and natrual killer (NK) cells by multiparameter flow cytometry. (2) the level of immune response to autochthonous viral and tumor antigens by interferon-gamma ELISPOT. (3) immunogenicity and pharmacokinetics of ALT-803. (4) overall objective response rate (ORR) and response duration.
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051406

NCI/CTEP #9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinic) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer

Primary Objective: To determine the maximum tolerated dose (MTD)and dose-limiting toxicities (DLT) of the combination of AZD6244 and cyclosporin A in adult patients with advanced solid tumors.
Seconday Objectives: (1) To determine the safety profile and tolerability of thsi regimen in this patient population. (2) To determine the pharmacokinetics of the combination. (3) To evaluate the selected biomarkers of drug effect in patients with advanced solid tumors or metastatic CRC. (4) Evaluate the activity of the combination in terms of objective response rate (per RECIST 1.1), overall survival, and progression-free survival.
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011411

R1979-HM-1333: An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an anti-CD20 x anti-CD3 bispecific monoclonal antibody, in Patients with CD20+ B-cell Malignancies previously treated with CD20 directed antibody therapy.

The primary objective of the study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) of REGN1979 administered intravenously (IV).

The secondary objectives of the study are:
* To characterize the pharmacokinetic (PK) profile of REGN1979
* To assess the immunogenicity of REGN1979
* To study the preliminary antitumor activity of REGN1979 administered to patients with CD20+ B-cell malignancies (non-Hodgkin's lymphoma [NHL] and chronic lymphocytic leukemia [CLL]) previously treated with anti-CD20 antibody therapy.
o Minimal residual disease (MRD) assessments in patients with CLL

The exploratory objectives of the study are:
* To evaluate biomarkers that may correlate with mechanism of action, observed toxicity, and potential anti-tumor activity including, but not limited, to:
o Cytokine profiling
o Peripheral blood B-cell and T-cell subsets and immune phenotyping
o Changes in gene expression in peripheral blood
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051506

CLDK378A2112: Phase I, multi-center, randomized open label study to assess the systemic exposure and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC.)

Primary Objective:
To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC.

Secondary objective:
To assess the safety profile (including frequency of patients with GI AEs by
severity and overall) of 450 mg or 600 mg ceritinib taken daily with a lowfat
meal as compared with that of 750 mg ceritinib taken daily in the fasted
state in patients with metastatic ALK-positive NSCLC

To assess the single-dose PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC

To assess the antitumor activity of ceritinib as measured by objective
response rate (ORR) and duration of response (DOR) in patients with
metastatic ALK-positive NSCLC following oral dosing of 450 mg or 600 mg
ceritinib taken daily with a low-fat meal as compared with that of 750 mg
ceritinib taken daily in the fasted state
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081506

Phase Ib and Phase II Studies of anti-PD-1 Antibody MK-3475 in Combination with Bevacizumab for the Treatment of Metastatic Renal Cell Carcinoma: Big Ten Cancer Research Consortium BTCRC-GU14-003

Phase Ib Dose Escalation Cohort: To establish the maximum tested safe dose of study drug pembrolizumab (MK-3475) and bevacizumab in combination for subjects with metastatic clear cell renal carcinoma after failure of at least one systemic therapy for metastatic disease.

Phase II Study: To determine the activity of combination of pembrolizumab and bevacizumab in first line therapy for subjects with treatment naïve metastatic clear cell RCC as assessed by response rates (complete or partial response) (RR) based on RECIST 1.1.
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051511

A Phase 1, Open-Label, Multicenter, Randomized, 2-Period, Crossover Study to Evaluate the Bioequivalence of CC-486 (Oral Azacitidine) Tablets in Adult Cancer Subjects

Primary Objective: To evaluate the bioequivalence of CC-486 (Oral Azacitidine) when administered once daily as one 300mg tablet relative to two 150mg tablets during the pharmacokinetics phase of the study in adult cancer subjects.
Secondary Objective: To evaluate the safety and tolerability of CC-486 (Oral Azacitidine) during the pharmacokinetics phase and Vidaza (Azacitidine for Injection) during the extension phase of the study in adult cancer subjects.
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051510

Phase I Study of Intratumoral CAVATAK (Coxsackievirus A21) and Pembrolizumab in Patients with Advanced Melanoma

2.1. Primary Objective

To assess the safety and tolerability of intravenous pembrolizumab with in combination with Intratumoral CAVATAK by incidence of dose-limiting toxicities (DLT).

2.2. Secondary Objectives

1. To assess the clinical efficacy of Pembrolizumab with in combination with Intratumoral CAVATAK in terms of of immune-related progression-free survival (irPFS) at 12 months, PFS hazard ratio, objective response rate (ORR), 1-year survival, overall survival (OS) and quality of life.
2. Assess the response of injected and non-injected melanoma deposits after CAVATAK and pembrolizumab.
3. Assess the time to initial response
4. Assess durable response rate at 6 months.
5. Assess peripheral blood for changes in T-cell phenotypes after CAVATAK and pembrolizumab.
6. Assess for T-cell immune response to known melanoma antigens during treatment.
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051512

NCI/CTEP #9681: A Phase I Study of Cabozantinib plus Nivolumab (CaboNivo) Alone or in Combination with Ipilimumab (CaboNivoIpi) in Patients with Advanced/Metastatic Urothelial Carcinoma and other Genitourinary Tumors

Primary Objective: Determine the dose limiting toxicity (DLT) and recommended Phase II dose (RP2D) of the combination of cabozantinib and nivolumab and separately the combination of cabozantinib, nivolumab and ipilimumab in patients with solid tumors
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051513

NCI/CTEP #9782: A Phase I Study of BMN 673 in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors

Primary Objectives: (1) To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BMN 673 seven day schedule in combination with carboplatin and paclitaxel. (2) To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BMN 673 three day schedule in combination with carboplatin and paclitaxel.
Secondary Objectives: (1) To observe and record anti-tumor activity of BMN 673 in combination with carboplatin and paclitaxel. Although the clinical benefit of these drugs in combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. (2) To determine whether the pharmacokinetic parameters of BMN 673 when given in combination with carboplatin and paclitaxel correlate with thrombocytopenia. (3) To observe and record anti-tumor activity of BMN 673 alone after the combination with carboplatin, paclitaxel and BMN 673. (4) To observe the safety and tolerability of BMN 673 in combination with paclitaxel and carboplatin and BMN 673 alone after the combination therapy.
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051515

A Phase I, Open-Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of Selumetinib (AZD6244 Hyd-sulfate) in Combination with MEDI4736 in Patients With Advanced Solid Tumours

The primary objective of this study is:
- To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies

The secondary objectives of this study are:
- To define the recommended dose for selumetinib in combination with
MEDI4736―a long term tolerated dose and exposure predicted to result in
biological activity (including but not limited to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 [see Appendix F] and tumour and
blood-borne biomarkers)
- To obtain a preliminary assessment of the anti-tumour activity of selumetinib in combination with MEDI4736 by evaluation of tumour response using RECIST,
version 1.1
- To characterise the population pharmacokinetics (PK) of selumetinib when
administered in combination with MEDI4736
- To characterise the population PK of MEDI4736, when administered in
combination with selumetinib
- To assess the immunogenicity of MEDI
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011505

A Phase I Study with an Expansion Cohort of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma

Primary Objective

1.To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab.

Secondary Objectives
1. To evaluate complete response (CR) rate, partial response rate (PR) and overall response rate (ORR), for the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab.
2. To evaluate the duration of remission (DOR) to these combinations and compare with the DOR achieved with the most recent prior systemic therapy.
3. To evaluate the progression-free survival (PFS) and the overall survival (OS) in patients receiving the combination of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab.

Correlative Studies
1. To evaluate the ability of these combinations of to alter tumor specific T cell immunity.
2. To evaluate a panel of cytokine and T cell specific biomarkers from the peripheral blood as a potential immune signature of treatment response to therapy with these combinations for patients with relapsed / refractory HL.
3. To evaluate using gene expression profiling (GEP) a signature of response to these novel combinations of an antibody drug conjugate with immunomodulatory therapy.
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011506

A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination with Polatuzumab Vedotin and Venetoclax in Patients with Relapsed or Refractory Follicular of Diffuse Large B-Cell Lymphoma

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of obinutuzumab in combination with polatuzumab vedotin and venetoclax (G + Pola + V) in patients with R/R FL or DLBCL, followed by post-induction treatment with G + V in patients with FL who achieve a CR, PR, or stable disease at end of induction (EOI) and in patients with DLBCL who achieve a CR or PR at EOI.
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