Find a Clinical Trial

Print this page
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.
(More)


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).
(More)


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.
(More)


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
(More)


091503

The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/2 Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma

1.1 Primary Objective
Phase 1: To determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.
Phase 2: To assess the clinical efficacy of HCQ+D+T by 1 year PFS rate .
1.2 Secondary Objectives
1.2.1 To estimate the toxicity rates of oral HCQ when administered in conjunction with oral D+T.
1.2.2 To measure the response rate by RECIST criteria, and 1-year survival.
1.2.3 To determine the rate of squamous cell carcinoma of the skin, arthralgias, and pyrexia in patients treated with D+T and HCQ
1.2.4 To determine the type and frequency of ocular toxicities with this regimen
1.3 Correlative Objectives
1.3.1 To establish a population pharmacokinetic (PK) model for HCQ and its metabolites in combination with D+T
1.3.2 To use the population PK model to estimate the exposure of HCQ in individual patients
1.3.3 To compare PK parameters for HCQ and D+T in combination to data from published dabrafenib and trametinib single agent and combination studies
1.3.4 To measure the change in median number of autophagic vesicles/cell (mAV/cell) in serially collected tumor tissue with D+T alone and with D+T + HCQ and correlate these changes with HCQ exposure
1.3.5 To determine if markers of T cell immunity are increased or decreased in D+T and D+T + HCQ treated tumor compared to baseline
1.3.6 To characterize changes in gene expression within the tumor microenvironment with D+T+ HCQ treatment in patients.
1.3.7 To evaluate whether or not treatment results in modulation of systemic immunity by assessing peripheral cytokine levels
1.3.8 To determine if blood based candidate biomarkers of autophagy modulation reflect autophagy dynamics in tumors of patients
(More)


031507

Moving PD-1 Blockade with Pembrolizumab into Concurrent Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

1) To assess safety and toxicity of PD-1 inhibition with pembrolizumab with concurrent chemoradiation therapy for non-operable, locally advanced non-small cell lung cancer
2) To evaluate local control and distant metastasis-free survival, progression-free and overall survival with the addition of pembrolizumab to chemoradiotherapy
3) To evaluate the rates of pneumonitis that may result from combination pembrolizumab and chemoradiotherapy
4) To assess whether PD-L1 status on immunohistochemistry is predictive of response to pembrolizumab when combined with chemoradiation therapy
5)To assess T cell (CD8+T cells and CD4+FoxP3+ regulatory cells) responses at weeks 1, 3, 6 during chemoradiation therapy and before each administration of pembrolizumab for cycles 1, 2, 3
(More)


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.
(More)


091306

NCI/CTEP# 9466: Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma and other solid tumors

1.1 Phase I Objectives
1.1.1 Primary Objective
1.1.1.1 To determine the maximum tolerate dose (MTD), toxicity, and safety profile of navitoclax when given in combination with dabrafenib and trametinib in patients with BRAF-mutant solid tumors.

1.1.2 Secondary Objectives
1.1.2.1 To describe pharmacodynamics effects of treatment with dabrafenib, trametinib, and navitocalx on both serial tumor biopsies and serial blood draws in a small subset of patients treated with BRAF-mutant melanoma.
1.1.2.2 To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and navitoclax.


1.2 Phase II Objectives
1.2.1 Primary Objectives
1.2.1.1 To estimate the complete response (CR) rate in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, and navitoclax as compared to the historical control.
1.2.1.2 To compare the maximal tumor regression in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax.


1.2.2 Secondary Objectives
1.2.2.1 To compare the PFS, OS, and ORR in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, versus dabrafenib, trametinib, and navitoclax.
1.2.2.2 To compare the degree of apoptosis induced in on-treatment biopsies of patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax.
1.2.2.3 To explore other pharmacodynamic effects in on-treatment biopsies of patients with BRAF-mutant melanoma treated with either dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax including cell proliferation (Ki-67), proteomics (RPPA), and BCL-2 family gene expression analysis.
(More)


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.
(More)


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.
(More)


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.
(More)


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.
(More)


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
(More)


051408

A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination with Pembrolizumab (MK-3475) in Patients with Previously Treated Metastatic Castration-Resistant Prostate Cancer

Primary objectives: Part A: to evaluate the safety and tolerability of ADXS31-142 monotherapy and select the RP2D in subjects with mCRPC. Part B: to evaluate the safety and tolerability of ADXS31-142 in combination with pembrolizumab (MK-3475) and to establish the RP2D for this combination in subjects with mCRPC.
Secondary Objective: to evaluate anti-tumor activity and progression free survival (PFS) signal of ADXS31-142 monotherapy and ADXS31-142 + pembrolizumab (MK-3475) combination therapy using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) and Prostate Cancer Working Group 2 (PCWG2) criteria to inform design of a subsequent randomized Phase 2 trial.
(More)


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
(More)


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.
(More)


051508

Protocol #: 20140318: A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

The primary objective of the study is to evaluate the maximum tolerated dose (MTD) of intrahepatic injection of talimogene laherparepvec into tumors of the liver, based on subject incidence of dose-limiting toxicities (DLTs), separately in subjects with primary hepatocellular carcinoma (HCC) and subjects with metastatic liver tumors (non-HCC).
The secondary objectives of the study are as follows:
* To evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver
tumors as assessed by subject incidence of treatment-emergent and
treatment-related adverse events
* To evaluate the efficacy of intrahepatic injection of talimogene laherparepvec in the overall population and by tumor type (non-HCC and HCC) as assessed by: objective response rate (ORR), best overall response (BOR), durable response rate (DRR), duration of response (DOR), response in injected and uninjected lesions, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
* To estimate the incidence of detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in blood and urine
* To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine
* To estimate the rate of detection and incidence of talimogene laherparepvec DNA and virus at the surface of talimogene laherparepvec injection site, the exterior of the occlusive dressing, and the oral mucosa
* To estimate the incidence of talimogene laherparepvec DNA detection in lesions
suspected to be herpetic in origin

The exploratory objectives of the study are to assess blood and tumor tissue for potential biomarkers which predict and/or are correlated with clinical outcomes to talimogene laherparepvec
(More)


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.
(More)


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
(More)


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.
(More)


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
(More)


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.
(More)


021601

A Phase 1, Open-label, Adaptive Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Anti-tumor Activity of ADCT-402 in Patients with Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia (B-ALL).

* Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of ADCT-402 in patients with relapsed or refractory B-ALL in Part 1.
* Determine the recommended dose of ADCT-402 for Part 2 (expansion).
* Evaluate the safety and tolerability of ADCT-402 in Part 2 (expansion) at the dose level recommended in Part 1.
(More)


091509

A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma

Phase Ib: To characterize the safety and tolerability, and subsequently identify the MTD or RP2D, of the combination of durvalumab or tremelimumab with IMCgp100 (Arms 1 and 2) and tremelimumab + durvalumab with IMCgp100 (Arm 3).
Phase II: To evaluate the ORR of IMCgp100 using RECIST v.1.1 criteria as a single agent (Arm 4) and in combination with checkpoint inhibition with durvalumab (Arm 1), tremelimumab (Arm 2), or the combination of durvalumab and tremelimumab (Arm 3).
(More)


031603

PrE0504: A Phase I/II Study of Glembatumumab Vedotin in Patients with gpNMB-Expressing, Advanced or Metastatic Squamous Cell Carcinoma of the Lung

The primary objective of the Phase I portion of the study is to evaluate the safety and tolerability and to determine the Maximum Tolerated Dose (MTD) of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung.

The primary objective of the Phase II portion of the study is to determine the anti-tumor activity, as assessed by objective response rate (ORR) in accordance with RECIST 1.1, of the MTD of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung.
(More)