Trial watch

Figures & data

Table 1. Clinical trials testing TAA-derived peptides as therapeutic interventions in patients affected by hematological neoplasms.*

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
ALL AML MDS	5	I	Not yet recruiting	Peptide	WT1	As single AA	NCT00725283
			Recruiting				NCT01051063
		I-II				Combined with Treg depletion	NCT01513109
		II				As single AA	NCT01266083
		n.a.				Combined with GM-CSF	NCT00665002
Hematological malignancies	1	I	Recruiting	Peptide	WT1	Combined with GM-CSF	NCT00672152
Multiple myeloma	5	n.a.	Enrolling by invitation	Peptide	MUC1	As single AA	NCT01423760
		I	Recruiting		MAGE-A3	As single AA	NCT01380145
		I-II	Active, not recruiting		CMV hTERT Survivin	Combined with GM-CSF and PCV	NCT00834665
			Recruiting		MUC1	Combined with GM-CSF	NCT01232712
		II			MAGE-A3	Combined with ASCT, lenalidomide, and immunostimulants	NCT01245673

Abbreviations: AA, adjuvanted agent; ALL, acute lymphocytic leukemia; AML, acute myeloid leukemia, ASCT, autologous stem cell transplantation; CMV, cytomegalovirus N495 peptide; GM-CSF, granulocyte macrophage colony-stimulating factor; hTERT, human telomerase reverse transcriptase; MAGE-A3, melanoma-associated antigen A3; MDS, myelodysplastic syndrome; MUC1, mucin 1; n.a., not available; PCV, pneumococcal conjugate vaccine; poly ICLC, polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethylcellulose; TAA, tumor associated antigen; Treg, FOXP3⁺ regulatory T cells; WT1, Wilms' tumor 1. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 2. Clinical trials testing TAA-derived peptides and/or full length proteins as therapeutic interventions in patients affected by neurological and pulmonary malignancies

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Astrocytoma	1	0	Active, not recruiting	Peptide	GAA	Combined with poly ICLC	NCT00795457
Brain cancer	1	I	Active, not recruiting	Peptide	TAAs	As single AA	NCT00935545
Glioblastoma multiforme	6	I	Recruiting	Peptide	IMA950	Combined with various immunostimulants	NCT01403285
						Combined with GM-CSF and radiotherapy	NCT01222221
		I-II	Active, not recruiting		EGFRvIII	Combined with chemotherapeutics	NCT00626015
		II				Combined with GM-CSF	NCT00643097
				HSP complex	HSPPC96	Combined with temozolomide	NCT00905060
		III	Recruiting	Peptide	EGFRvIII	Combined with GM-CSF and temozolomide	NCT01480479
Glioma	4	n.a.	Recruiting	Peptide	GAA	Combined with poly ICLC	NCT01130077
		0	Active, not recruiting				NCT00874861
		I	Recruiting		EGFRvIII	As single AA	NCT01058850
					Survivin	Combined with GM-CSF	NCT01250470
Lung cancer	1	I-II	Recruiting	Peptide	NY-ESO-1	As single AA	NCT01584115
Neuroblastoma	1	I	Active, not recruiting	Peptide	GD2L GD3L	Combined with KLH and oral β-glucan	NCT00911560
NSCLC	15	n.a.	Enrolling by invitation	Peptide	MUC1	As single AA	NCT01423760
		I	Recruiting		CDCA1 KIF20A URLC10		NCT01069575
					IDO		NCT01219348
					URLC10		NCT01069640
				FL protein	MAGE-A3	Combined with CDDP, radiotherapy or vinorelbine	NCT00455572
			Unknown	Peptide	CDCA1 URLC10 VEGFR1/2	As single AA	NCT00874588
					TTK URLC10 VEGFR1/2		NCT00633724
		I-II			KOC1 TTK URLC10		NCT00674258
					URLC10 VEGFR1/2		NCT00673777
		II	Recruiting	Vector	RAS		NCT00655161
				Peptide	CTAs		NCT01592617
		III	Not yet recruiting		hTERT	Combined with GM-CSF	NCT01579188
					MUC1	Combined with cyclophosphamide	NCT00409188
				FL protein	MAGE-A3	As single AA	NCT00480025
			Recruiting	Peptide	MUC1	Combined with cyclophosphamide	NCT01015443
SCLC	1	I	Recruiting	Peptide	CDCA1 KIF20A	As single AA	NCT01069653

Abbreviations: AA, adjuvanted agent; CDCA1, cell division cycle-associated 1; CDDP, cisplatin; EGFR, epidermal growth factor receptor; FL, full-length; GAA, glioma-associated antigen; GM-CSF, granulocyte macrophage colony-stimulating factor; HSP, heat-shock protein; HSPPC96, HSP-peptide vaccine 96; hTERT, human telomerase reverse transcriptase; KIF20A, kinesin family member 20A; KLH, keyhole limpet hemocyanin; KOC1, K homology domain containing protein overexpressed in cancer; MAGE-A3, melanoma-associated antigen A3; n.a., not available; NSCLC, non-small cell lung carcinoma; poly ICLC, polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethylcellulose; SCLC, small cell lung cancer; TAA, tumor associated antigen; URLC10, upregulated gene in lung cancer 10; VEGFR, vascular endothelial growth factor receptor. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 3. Clinical trials testing TAA-derived peptides and/or full length proteins as therapeutic interventions in patients affected by breast, ovarian and prostate carcinoma

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Breast cancer	16	n.a.	Active, not recruiting	Peptide	HER2 MUC1	Combined with CpG ODNs and/or GM-CSF	NCT00640861
			Recruiting		CEA CTAs HER2	As single AA	NCT00892567
						Combined with poly ICLC and tetanus toxoid peptide	NCT01532960
					CMV hTERT Survivin	Combined with basiliximab, GM-CSF and prevnar	NCT01660529
		0			MUC1	Combined with poly ICLC	NCT00986609
		I			CDCA1 DEPDC1 KIF20A MPHOSPH1 URLC10	As single AA	NCT01259505
					FRα	Combined with cyclophosphamide	NCT01606241
					HER2	As single AA	NCT01632332
		I-II	Active, not recruiting		HER2	Combined with lapatinib	NCT00952692
					HER2	Combined with GM-CSF	NCT00841399
							NCT00854789
			Recruiting			Combined with GM-CSF and cyclophosphamide	NCT00791037
						Combined with rintatolimod and/or GM-CSF	NCT01355393
		II	Not yet recruiting			Combined with anti-HER2 mAb and GM-CSF	NCT01570036
			Recruiting		WT1	As single agent	NCT01220128
		III			HER2	Combined with GM-CSF	NCT01479244
Ovarian cancer	3	I-II	Recruiting	Peptide	FBP	Combined with GM-CSF	NCT01580696
				FL protein	NY-ESO-1	As single AA	NCT01584115
				Peptide	p53	Combined with gemcitabine and pegylated IFNα-2b	NCT01639885
Prostate cancer	5	n.a.	Active, not recruiting	Peptide	PSMA TARP	Combined with poly ICLC	NCT00694551
		I			TARP	Combined with ex vivo TARP peptide-pulsed DCs	NCT00972309
			Recruiting		LAGE1 NY-ESO-1	As single AA	NCT00711334
		I-II	Unknown		CDCA1		NCT01225471
					GnRH		NCT00895466

Abbreviations: AA, adjuvanted agent; CDCA1, cell division cycle-associated 1; CEA, carcinoembryonic antigen; CMV, cytomegalovirus pp65 peptide; CTA, cancer-testis antigen; DC, dendritic cell; DEPDC1, DEP domain containing 1; FBP, folate binding protein; FL, full length; FR, folate receptor; GM-CSF, granulocyte macrophage colony-stimulating factor; GnRH, gonadotropin releasing hormone; hTERT, human telomerase reverse transcriptase; IFN, interferon; KIF20A, kinesin family member 20A; mAb, monoclonal antibody; MPHOSPH1, M-phase phosphoprotein 1; MUC1, mucin 1; n.a., not available; poly ICLC, polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethylcellulose; PMSA, prostate membrane-specific antigen; ODN, oligodeoxynucleotide; TAA, tumor associated antigen; TARP, T-cell receptor gamma chain alternate reading frame protein; URLC10, upregulated in lung cancer 10; WT1, Wilms’ tumor 1. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 4. Clinical trials testing TAA-derived peptides and/or full-length proteins as therapeutic interventions in melanoma patients

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Melanoma	25	n.a.	Recruiting	Peptide	Class I-restricted peptides	Combined with IFNγ	NCT00977145
						Combined with imiquimod	NCT01264731
		0	Recruiting	Peptide	MAGE-A3	As single AA	NCT01425749
		I	Active, not recruiting	Peptide	gp100 MART-1 NY-ESO-1	Combined with poly ICLC ± anti-CD40-mAb	NCT01008527
					gp100	Combined with pegylated IFNα-2b	NCT00861406
					MAGE-A3	Combined with dacarbazine	NCT00849875
			Not yet recruiting		Class I-restricted peptides	Combined with LPS or poly ICLC	NCT01585350
			Recruiting		gp100 MART-1 NY-ESO-1	Combined with anti-PD1 mAb	NCT01176461
			Recruiting				NCT01176474
			Recruiting		PRAME	As single AA	NCT01149343
		I-II	Recruiting	FL protein	NY-ESO-1	As single AA	NCT01584115
					NY-ESO-1	Combined with poly ICLC	NCT01079741
				Peptide	LAG3 MAGE-3.A2 NA-17 NY-ESO-1	As Single AA	NCT01308294
				Vector	Tyrosinase		NCT01331915
			Unknown	Peptide	MAGE-3.A1 NA17.A2	Combined with GM-CSF, IFN-α, IL-2 and imiquimod	NCT01191034
		II	Active, not recruiting	Peptide	MAGE-A3	As single AA	NCT00896480
						As single AA	NCT00942162
					MART-1	Combined with anti-MART-1TCR-expressing PBLs ± IL-2	NCT00706992
					Not better specified	Combined with GM-CSF and a tetanus helper peptide	NCT00938223
			Recruiting		gp100 MAGE-3	As single AA ± resiquimod	NCT00960752
					gp100 MAGE-3.1 MART-1 NA17-A2	Combined with daclizumab ± IL-12	NCT01307618
					IDO survivin	Combined with GM-CSF, imiquimod and temozolomide	NCT01543464
					MAGE-A3	As single AA ± poly ICLC	NCT01437605
						As single AA ± IL-2	NCT01266603
		III	Active, not recruiting	Peptide	MAGE-A3	As single AA	NCT00796445

Abbreviations: AA, adjuvanted agent; FL, full-length; GM-CSF, granulocyte macrophage colony-stimulating factor; gp100, glycoprotein 100; IDO, indoleamine 2, 3-dioxygenase; IFN, interferon; IL, interleukin; LAG3, lymphocyte-activation gene 3; LPS, lipopolysaccharide; mAb, monoclonal antibody; MAGE, melanoma-associated antigen; MART-1, melanoma antigen recognized by T-cells 1; n.a., not available; PBL, peripheral blood lymphocyte; poly ICLC, polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethylcellulose; PRAME, preferentially expressed antigen in melanoma; TAA, tumor associated antigen; TCR, T-cell receptor. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 5. Clinical trials testing TAA-derived peptides and/or full-length proteins as therapeutic interventions in patients affected by esophageal, gastric, pancreatic and colorectal carcinoma

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Colorectal carcinoma	4	I	Unknown	Peptide	RNF43	As single AA	NCT00641615
		II	Recruiting		GI-4000	Combined with bevacizumab and/or FOLOFOX or FOLFIRI	NCT01322815
					MUC1	Combined with chemoradio-therapy and cyclophosphamide	NCT01507103
						Combined with poly ICLC	NCT00773097
Esophageal carcinoma	5	I	Active, not recruiting	FL protein	NY-ESO-1	As single AA complexed with CHP	NCT01003808
			Unknown	Peptide	IMP3 LY6K TTK	As single AA	NCT00682227
					KOC1 TTK URLC10 VEGFR1/2	Combined with cisplatin and 5-FU	NCT00632333
		I-II	Recruiting		TTK URLC10	Combined with CpG ODNs	NCT00669292
		II			CDCA1 KOC1 URLC10	As single AA	NCT01267578
Gastric cancer	1	I-II	Recruiting	Peptide	VEGFR1	As single AA	NCT01227772
Pancreatic carcinoma	5	I	Active, not recruiting	Peptide	hTERT	Combined with gemcitabine, GM-CSF and tadalafil	NCT01342224
					VEGFR1/2	Combined with gemcitabine	NCT01266720
			Unknown				NCT00639925
		I-II			VEGFR1	As single AA	NCT00683358
					VEGFR1/2	Combined with gemcitabine	NCT00655785

Abbreviations: 5-FU, 5-fluorouracil; AA, adjuvanted agent; CDCA1, cell division cycle-associated 1; CHP, cholesterol-bearing hydrophobized pullulan; FL, full-length; FOLFIRI, folinic acid, 5-FU, irinotecan; FOLFOX, folinic acid, 5-FU, oxaliplatin; GM-CSF, granulocyte macrophage colony-stimulating factor; hTERT, human telomerase reverse transcriptase; IMP3, insulin-like growth factor II mRNA-binding protein 3; KOC1, K homology domain containing protein overexpressed in cancer; LY6K, lymphocyte antigen 6 complex locus K; MUC1, mucin 1; ODN, oligodeoxynucleotide; poly ICLC, polyriboinosinic-polyribocytidylic acid stabilized with poly-L-lysine in carboxymethylcellulose; TAA, tumor associated antigen; URLC10, upregulated in lung cancer 10; VEGFR, vascular endothelial growth factor receptor. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 6. Clinical trials testing TAA-derived peptides and/or full-length proteins as therapeutic interventions in patients affected by bladder carcinoma and tumors of the reproductive tract

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Bladder cancer	3	II	Enrolling by invitation	Peptide	MAGE-A3	As single AA ± BCG	NCT01498172
			Recruiting	FL protein	MAGE-A3	As single AA	NCT01435356
			Unknown	Peptide	DEPDC1 MPHOSPH1		NCT00633204
Endometrial cancer	1	I-II	Recruiting	Peptide	FBP	Combined with GM-CSF	NCT01580696
Reproductive tract cancer	6	I	Active, not recruiting	FL protein	NY-ESO-1	Combined with GM-CSF, decitabine and doxorubicin	NCT00887796
							NCT01673217
				Peptide	Seven TAAs	As single AA	NCT01095848
			Recruiting		FRα	Combined with cyclophosphamide	NCT01606241
				Virus	NY-ESO-1	Combined with GM-CSF and rapamycin	NCT01536054
		I-II		Peptide	Survivin	Combined with cyclophosphamide	NCT01416038

Abbreviations: AA, adjuvanted agent; BCG, bacillus Calmette-Guérin; DEPDC1, DEP domain containing 1; FBP, folate-binding protein; FL, full-length; FR, folate receptor; GM-CSF, granulocyte macrophage colony-stimulating factor; MAGE-A3, melanoma-associated antigen A3; MPHOSPH1, M-phase phosphoprotein 1; TAA, tumor associated antigen.. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.

Table 7. Clinical trials testing TAA-derived peptides and/or full length proteins as therapeutic interventions in patients affected by additional tumor type and in mixed patient cohorts

Tumor type	Trials	Phase	Status	Type	TAAs	Co-therapy	Ref.
Bile duct cancer	1	I	Recruiting	Peptide	URLC10	Combined with gemcitabine	NCT00624182
Head and neck carcinoma	1	I	Unknown	Peptide	HPV-16 antigens MAGE-A3	As single AA	NCT00704041
Hepatocellular carcinoma	1	I	Recruiting	Peptide	VEGFR1/2	As single AA	NCT01266707
HER2^+ cancers	1	I	Not yet recruiting	Virus	HER2	As single AA	NCT01526473
HPV-induced cancers	1	I-II	Recruiting	Peptide	p16^INK4a	As single AA	NCT01462838
Mesothelioma	2	II	Recruiting	Peptide	WT1	Combined with GM-CSF	NCT01265433
			Not yet recruiting	Virus	5T4	As single AA	NCT01569919
Metastatic solid tumors	1	I	Recruiting	Peptide	HER2	As single AA	NCT01376505
NY-ESO-1^+ tumors	1	I	Recruiting	FL protein	NY-ESO-1	Combined with CpG ODNs ± cyclophosphamide	NCT00819806
Solid tumors	2	I	Recruiting	Peptide	MUC-1	As single AA	NCT01556789
					WT1		NCT01621542
Various tumors	1	I	Unknown	FL protein	NY-ESO-1	Combined with resiquimod	NCT00821652

Abbreviations: AA, adjuvanted agent; FL, full-length; GM-CSF, granulocyte macrophage colony-stimulating factor; HPV, human papillomavirus; MAGE-A3, melanoma-associated antigen A3; MUC-1, mucin 1; ODN, oligodeoxynucleotide; TAA, tumor associated antigen; URLC10, upregulated in lung cancer 10; VEGFR, vascular endothelial growth factor receptor; WT1, Wilms’ tumor 1.*. *started after January, 1st 2008 and not withdrawn, terminated or completed at the day of submission.